Cement, Dental

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Shandong and Guangdong: 3 hold an FDA registration.

Rizhao Huge Biomaterials Company, Ltd. Shandong
Shenzhen Upcera Dental Technology Co., Ltd. Guangdong
Shandong Huge Dental Material Corporation Shandong

What Is FDA Product Code EMA?

Cement, Dental is FDA product code EMA, Class 2, 21 CFR 872.3275.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 5 clearances under this code; the FDA took a median of 101 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 16 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (4), Process control (4) and Storage (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Capo Flow B 3, 2 G

Catalogue number 234308, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Bulk Fill Composite C2 Unit Dose 50 Pkg

Catalogue number H-9334C2P, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

ANA Glass Shade A2 25 Pack

Catalogue number 1803000, listed by Wykle Research, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Nexus Universal Automix Tips – Wide 50pk

Automix Tips

NanoPaq a 1, 0.3 G

Catalogue number 234610, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq Incisal White, 4 G

Catalogue number 234540, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

OverCEM SA Translucent Starter Kit

Catalogue number OverCEM SA Translucent Starter Kit, listed by Overfibers SRL, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Vivid TempFil White/X-Hard

38gm

TPH®3 Flow Liquid Micro Hybrid Restorative

TPH®3 Flow Syringe Sampler

Recap-It

Recapit is a Eugenol free temporary dental cement for re-cementing loose caps or crowns.

NanoPaq Opakdentin B 2, 4 G

Catalogue number 234533, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Telio CS Cem Implant

2 catalogue numbers from 637510AN, listed by Ivoclar Vivadent Aktiengesellschaft, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Nexus Universal Trial Kit

Syringe (Clear), Automix Tips and Optibond Universal (pawn w/micro-brush).

NanoPaq Opakdentin B 2, 0.3 G

Catalogue number 234633, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Oxford Glaze Intra

Light Cure Varnish for Provisional Crowns & Bridges

Harvard Ionoglas Cem Extra OptiCaps, Shade Universal

Esthetic glass ionomer cement for luting and lining

SciPharm Glasion Glass Ionomer Powder Jar, Boxed

Catalogue number SP 50-021 B, listed by Scientific Pharmaceuticals, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Provi Bond, 5 Ml

temporary cement, non eugenol

Vivid Silver Cem

Catalogue number D590060, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

ZirCAD Cement

ZirCAD Cement Refill 8.5 g (US)

Refil-It

Refilit is a Eugenol free temporary dental cement for replacing lost fillings.

Flexi-Flow Gray

Post Cement Paste/Paste Chemical Cure Gray Shade

Estemp NE Temporary Cement

EsTemp NE is a light-curing temporary dental filling material. The filing describes its use for cementation of temporary and provisional restorations, including crowns, bridges, inlays and…

3m™ Ketac™ Cem Maxicap™

3M™ Ketac™ Cem Maxicap™ Capsule Permanent Glass Ionomer Luting Cement Refill, 56021

Vivid Glass Restorative A2 Std Pkg

Catalogue number D440768, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Medental

P.C.A. Cement kit 25gr. 15ml.

Freegenol™

FREEGENOL™ Standard Package (55g base, 20g catalyst, & mixing pad)

TempoLok NE Cement 2x5ml Syringe, 20 Mixing Tips

Temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be…

SciPharm Glasion Glass Ionomer Liquid Bottle, Boxed

Catalogue number SP 50-022 B, listed by Scientific Pharmaceuticals, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Temp-Bond NE

Temporary Crown and Bridge Cement Zinc Oxide Unidose

Polycarb Waterset

Water Activated Polycarboxylate Cement

Capo Hybrid a 3, 5 G

Catalogue number 232022, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Slow Flow Clear, 2 G

Catalogue number 232068, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Nexus Universal Sample – Clear With Chroma

Syringe (Clear with Chroma), Automix Tips

VistaCORE 5ml Syringe Shade White Opaque

VistaCORE 5ml Syringe Shade White Opaque: 1 catalogue number listed by Vista Dental, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural Incisal Clear, 4 G

Catalogue number 232050, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Zenith Implant Screw Mask

Dental Implant Screw Mask

AHfilSilver

Silver Rein GI 15g/7ml

C&B (1 Dual Syr) Natural

Catalogue number B-22210, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Pearl Composite Luting Cement Syringe System

Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and…

Bisico Cementime DC

Dual-curing, semipermanent luting cement for crowns and bridges on dental implants

Ti-Core Auto

Core Material Syringeable Dual Cure Natural Shade A2

AElite Fill Syringe Package

Catalogue number H-94010P, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Dentastic UNO Sample

Adhesive, dentine, applicator brush

OverCEM Ti-Abutment Starter Kit

Catalogue number OverCEM Ti-Abutment Starter Kit, listed by Overfibers SRL, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Harvard Ionoglas Cem Extra, Shade Universal

Esthetic glass ionomer cement for luting and lining

ONE-Step Adh. Primer 2ml Smpl

Catalogue number U-2003S, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Zero-G Bio Implant Cement

ZERO-G™ is a dual-cure implant cement and is recommended for intermediate to long-term cementation of implant-retained restorations. Retrievable, easy to see, simple removal of excess…

AuraCem DC90 Resin Cement

Catalogue number Off White, listed by Denali Corporation, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Hybrid a 3.5, 5 G

Catalogue number 232035, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural Bleach 1, 4 G

Catalogue number 232052, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AElite Fill Syringe

Catalogue number H-94001, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Harvard Ionoglas Fill Extra A2

Catalogue number 7052112, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Multilink Automix

2 catalogue numbers from 613627WW, listed by Ivoclar Vivadent Aktiengesellschaft, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Hybrid a 4, 5 G

Catalogue number 232023, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

One Step Plus U/Dose in Pouch

Catalogue number U-2021P, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

PCA Cement KIT 60GM/40ML

Catalogue number FP-NOVOINC-143, listed by Septodont, Inc, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Integrity® Temporary Crown and Bridge Material

Integrity® Temporization Procedure Kit

NanoPaq B 1, 0.3 G

Catalogue number 234615, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Novocol Granitec Orthodontic ADH LC 40-0.35 REF

Catalogue number FP-NOVOINC-166, listed by Septodont, Inc, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

RelyX™ Temp NE

3M™ ESPE™ RelyX™ Temp Ne Temporary Cement Zinc Oxide Non-Eugenol Refill, 56660

NanoPaq Flow C 3, 2 G

Catalogue number 234721, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Meron Plus

Resin reinforced glass ionomer luting cement. Liquid 10 ml.

Nexus Rmgi

Resin-Modified Glass Ionomer Luting Cement; Sample (NA) - Not For Resale

SciPharm Glass Ionomer Restorative, Liner, and Cement

Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restorations, permanent cementation of crowns and bridges, cementation of orthodontic bands, and…

Novocol Granitec Blue Band Cement Light Cure KIT

Novocol GRANITEC BLUE BAND CEMENT LIGHT CURE KIT- 6/pk

Ultiment-Sample

Sample OF Ultiment Implant/Crown AND Bridge Cement

Ceramir® Restore QuikCap

Ceramir Restore QuikCap is a self-curing dental restorative material combining glass-ionomer and calcium-aluminate ceramic cement technologies. It is used for applications including…

Insure® Lite Automix

Insure® Lite Automix, Syringe 8g

Oxford Temp CEM Universal

Catalogue number 32-002, listed by First Scientific Dental Materials GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq a 2, 4 G

Catalogue number 234511, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Flow Set

Catalogue number 234012, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural B 3, 4 G

Catalogue number 232046, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

OverCEM SA Opaque

Catalogue number OverCEM SA Opaque, listed by Overfibers SRL, under Cement, Dental. 3 manufacturers in China are registered for this product code.

High-Q-Bond Adhesive Resin Cement Automix

Catalogue number 100050AM, listed by B.J.M. Laboratories Ltd, Israel, under Cement, Dental. 3 manufacturers in China are registered for this product code.

PAA Tooth Conditioner

PAA Tooth Conditioner Filled & Labeled 15 ml Bottle Kit

Capo Hybrid a 2, 0.3 G

Catalogue number 232121, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural Incisal White, 4 G

Catalogue number 232051, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Reso-Pac Hydrophilic Periodontal Dressing

Reso-Pac Hydrophilic Periodontal Dressing (1000 x 2g Single-Use Cups)

Connect

Catalogue number 624302, listed by Cosmedent, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Olympian-M Temporary Cement, Syringe Part A

Catalogue number 0002, listed by Dent ZAR, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq B 3, 4 G

Catalogue number 234517, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Nexus Universal Refill Kit – White

Nexus Universal Syringe (White), Automix Tips (Wide and Regular)

Anchor 5ml Syringe Shade A2

Anchor 5ml Syringe Shade A2: 1 catalogue number listed by Vista Dental, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Provicol QM Aesthetic

Catalogue number 1108, listed by Voco Gmbh, Germany, under Cement, Dental. 3 manufacturers in China are registered for this product code.

ZOE Temporary Liquid 12ml (SDC Catalogue)

Discountinued

Harvard Ionoglas Fill Extra OptiCaps A2

2 catalogue numbers from 17729, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Repair Regular

Repair REG Fibered Pink 7 LB

NanoPaq IR (Incisal Red), 4 G

Catalogue number 234547, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Envy Self Adhesive Resin Cement-A2 Shade

Resin Cement Syringeable Dual Cure A2 Shade

SciPharm Glasion Glass Ionomer Cement, Spanish

Catalogue number SP 50-02 S, listed by Scientific Pharmaceuticals, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Harvard Ionoresin Fill A3,5

Catalogue number 7071117, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AxioCem Bioactive

Catalogue number 24004, listed by Axiodent Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Glisten™ Provisional Resin Glaze

Provisional Resin Glaze

NanoPaq D 3, 4 G

Catalogue number 234552, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AZ Primer

Catalogue number 3232, listed by Shofu Dental Corp., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Hybrid C 2, 5 G

Catalogue number 232026, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Ceramir Crown & Bridge QuikCap

Ceramir Crown & Bridge QuikCap Capsule

C&B Base Opaque 4gm Syr.

Catalogue number B-2212Q, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

C&B (1 Dual Syr) Pkg – Opaque

Catalogue number B-22110P, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Glass Ionomer Cement KIT 15GM/15ML

Catalogue number FP-NOVOINC-129, listed by Septodont, Inc, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Pearson Polycarboxylate Cement Triple Kit

Catalogue number C660005, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

AxioCem Type I

Catalogue number 24001, listed by Axiodent Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural C 2, 4 G

Catalogue number 232047, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Metacem A3

Metacem is a resin cement for permanently attaching indirect dental restorations to tooth structure. It is used with a dentin and enamel adhesive priming and bonding system for crowns,…

Total C-RAM

3 catalogue numbers from TRANSLUCENT, listed by Itena Clinical, Canada, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Oxford Temp CEM Flexi-Trans

Dual Cure Translucent Temporary Cement

Study Model

Study Model 1-OZ Liquid&Powder Sample

Zcem Carb

Zinc Polycarb Cement 90g/30ml

Capo Hybrid Incisal Medium, 5 G

Catalogue number 232028, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Vanish™

3M™ ESPE™ Vanish™ XT Extended Contact Varnish Refill, 12148

DT Post Placement Kit

Catalogue number G-91730K, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Z-Cem SA

Z-Cem SA Translucent 6g Dual Syringe Pkg

Tokuso Ceramic Primer

Catalogue number 16543, listed by Tokuyama Dental Corporation, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Scott’s Select Temp Automix NE 11gm

Catalogue number 199-1045, listed by Scott's Dental Supply L.L.C., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Vivid Zinc Cem

Powder and liquid 32g/ 17.5ml

ZOE Temporary Powder 20g (SDC Catalogue)

HY-B ZOE Cement PWD

Harvard Ionoglas Fill A3

Classical glass ionomer restorative cement

Vitrebond™

7571S VITREBOND PLUS LIGHT CURE GI LINER/BASE - Sample Pack

Alpha-Dent® Glass Ionomer Cement

ALPHA-DENT® Glass Ionomer Cement is specially formulated for superior strength, resistance to dissolution, and oral retention. They are impervious to oral fluids, and thus permanent under…

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer