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.

Harvard Cement Quick Setting, Clinic Liquid

Catalogue number 7001300, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Futurabond U

Dual-curing universal adhesive.

Hardcore®

CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASING KIT: 20 gm base + 20 gm dual catalyst, 20 core forms, mixing pad, spatulas

Bifix Veneer Try-In

Bifix Veneer Try-In is a water-soluble, coloured glycerine paste. The shade appearance of the cured Bifix Veneer LC can be simulated by inserting the permanent restoration with Bifix Veneer…

Capo Slow Flow Capsules a 1, 20 X 0.25

Catalogue number 232112, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

TheraCem Ca

THERACEM Ca 1G DUAL SYR SAMPLE

ZR-Cem

ZR-Cem Shade Translucent Sample

3m™ Ketac™ Universal Aplicap™

3M™ Ketac™ Universal Aplicap™ Glass Ionomer Restorative Assorted Shade Refills White, A2, A3, 61085

Vivid Core Cem

Catalogue number A590034, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Polycarboxylate

HY-Bond Poly Liquid

UltraTemp

Sample UltraTemp Rez Fast Set

OverCEM Ti-Abutment

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

Multilink Automix / Primer A+B

Multilink Primer A+B Refill 2 x 3 g

3m™ Espe™ Ketac™

3M™ ESPE™ Ketac™ Cem Radiopaque Glass Ionomer Luting Cement Triple Size, 37231

Calibra® Veneer Esthetic Resin Cement

Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Translucent, 1 syringe (2g)

C&B Cat. 4g Syringe

Catalogue number B-2211Q, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural a 3, 4 G

Catalogue number 232042, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AHfIlLC

LC GI Rest Cem 15g/6ml A3

Flexi-Flow Sample Natural

Post Cement Paste/Paste Chemical Cure Natural Shade A3 Sample

Estecem II

Paste White Opaque

Capo Natural Set

Catalogue number 232055, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Harvard Cement Normal Setting, Clinic Powder, Shade 1

8 catalogue numbers from 7002201, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Zinroc Powder

Powder FOR Mixing With Dental Cement Liquid

Brasseler USA

Activ Liquid GP Cement 1P Activ GP Cement Liquid

Parkell®

Clear Mixing Tip with Brown Base

Insure® Universal AutoMix

Insure® UNIVERSAL AutoMix Yellow Red Universal, Syringe 8g

Calibra® Bio

Calibra® Bio Evaluator Kit

SpeedCEM / SpeedCEM Plus

Speedcem Plus Refill 3x9g transp.

Vivid CaviTemp Pink

30g

Dentocem

Catalogue number DCA-2.5, listed by Itena Clinical, Canada, under Cement, Dental. 3 manufacturers in China are registered for this product code.

SciPharm Fastil Saliva-Cured Temporary Restorative

Fastfil - A Saliva-Cured Temporary Restorative Jar. Non-Boxed. Spanish

0.25g Bulk Fill Comp. 3 U/D A2 Sample

Catalogue number H-9330A2S, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Riva CEM

Riva Cem is a resin-modified glass-ionomer luting cement for permanent dental cementation. Its radiopaque, fluoride-releasing formulation is supplied as base and catalyst pastes in a…

Ketac™ Universal Aplicap™

3M™ ESPE™ Ketac™ Universal Aplicap™ Refill Assorted, 50 Capsules, 61085

Panavia™ Veneer LC

Paste Trial (Soft White (B0.5))

NanoPaq Flow B 2, 2 G

Catalogue number 234716, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

RelyX™ Ultimate

3M™ ESPE™ RelyX™ Ultimate Adhesive Resin Cement Trial Kit - Translucent, 56892

UltraTemp REZ II

UltraTemp REZ II is a temporary resin cement used to retain provisional dental restorations. Its low viscosity, hydrophilic formula is intended for temporary crowns, bridges, inlays and…

Panavia™ F 2.0 Complete Kit

2 catalogue numbers from #502-KA, listed by Kuraray Noritake Dental, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AuraCem DC 90

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

Nexus Universal Intro Kit

Nexus Universal Syringes(s): Clear with Chroma, Nexus Universal Clear, Nexus Universal White, Nexus Universal Yellow, Automix Tips and Optibond Universal bottle w/mixing well.

Temrex Liquid

Liquid FOR Mixing With Dental Cement Powder

Prevue®

Prevue® Yellow-Red Universal, Syringe 2.5g

SciPharm Glasion Glass Ionomer 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…

EnaCem HF

ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5…

SmartCem®2 Self-Adhesive Cement

SmartCem®2 Self-Adhesive Cement Syringe Refill, Translucent

CLING2™ 5ml Dual Syringe Kit

Catalogue number 158900, listed by Clinician'S Choice Dental Products, Inc., Canada, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq B 2, 4 G

Catalogue number 234516, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Riva

2 catalogue numbers from RIVA ASSORTED GIC FAST SET KT, listed by SDI Ltd., Australia, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Flow a 1, 2 G

Catalogue number 234301, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Hybrid Occlusal White, 5 G

Catalogue number 232030, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Hardcore® – Core Build-UP Material – Dual Cure, Fluoride Releasing

Refill: 10 gm each HardCore Base and Catalyst

Temp. Crown&Bridge

Temp. Crown&Bridge Medium Powder 3OZ

Temp-Bond

Clear; Temporary Crown and Bridge Cement With Triclosan

Grandio SO Inlay System

Set for chairside fabrication of iindirect composite inlays.

Capo Hybrid Occlusal Clear, 5 G

Catalogue number 232029, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Vivid TempFill

Catalogue number D440744, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

3m™ Ketac™

3M™ Ketac™ Conditioner Refill, 37470

Meron Plus QM

resin-reinforced glass ionomer luting cement

Pearson TempFill Material

Pink X4

NX3

Nexus Third Generation; Dual-Cure Resin Cement; Automix Dual-Cure Syringe; White Opaque; Refill

Voco Ionofil Molar AC Quick

Glass ionomer restorative material. This set contains 48 application capsules (8 X A1, 8 X A2, 32 X A3) and Final Varnish LC bottle 3 ml.

Capo Slow Flow Capsules a 3, 20 X 0.25

Catalogue number 232114, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Cavex Temporary Cement

Catalogue number CE090, listed by Cavex Holland B.V., Netherlands, under Cement, Dental. 3 manufacturers in China are registered for this product code.

0.25g Bulk Fill Composite C2 Unit Dose

Catalogue number H-933C2, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AxioCem Type II Capsules

Catalogue number 24003, listed by Axiodent Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq Opakdentin a 2, 0.3 G

Catalogue number 234630, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

SpeedCEM

SpeedCEM Plus Test Pack transp., SpeedCEM Plus System Kit transp.

Liquid Cold

8-OZ Liquid Cold Cure-Tooth Shade

Ceramir Crown & Bridge QuikMix

Ceramir Crown & Bridge QuikMix Powder 15g

C&B Base Natural W/f 4gm Syr

Catalogue number B-2213QF, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

G-CEM™

G-CEM™ Starter Package (1 x 50 capsule assorted package, 1 x Capsule Applier)

Glidewell Rmgi Cement

Glidewell RMGI cement 2X0.4gm

HY-Temporary Soft

HY-Bond Poly Temp CEM 60/30

OverCEM SA Universal

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

Calibra® Abutment

Calibra® Abutment Resin Cement Syringe Refill

Ketac™ Cem Maxicap™

3M™ ESPE™ Ketac™ Cem Maxicap™ Glass Ionomer Luting Cement Refill, 50 Capsules, 56020

Metacem TL

2 catalogue numbers from 9409, listed by Meta Biomed Co., Ltd., South Korea, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Embrace Wetbond Restoration & PFM Repair KIT

Kit: 1.2 mL syringe each First-Coat, Seal-n-Shine, Opaquer, Porcelain Etch Gel, Kool Dam + accessories

ONE-Step Plus Adh. 2ml Smpl

Catalogue number U-2002S, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

GC Temp Advantage®

GC TEMP ADVANTAGE® Starter Package (1 x 7.5g syringe and 15 x mixing tips)

GC Fuji I®

GC Fuji I® 1:1 Kit Light Yellow (1 x 35 g powder, 1 x 20 mL liquid, accessories)

Insure® Lite

Insure® Lite Yellow-Red Universal, Syringe 3g

Henry Schein Natural Elegance

Self-Adhesive Resin Cement - Translucent

NanoPaq Incisal White, 0.3 G

Catalogue number 234640, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

DUO Link Base 4gm Syr

Catalogue number A-1901B, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

SciPharm Glasion Glass Ionomer Powder Jar

Catalogue number SP 50-031, listed by Scientific Pharmaceuticals, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Zone

Zinc Oxide NonEugenol Temporary Cement Unit Dose Packages (0.75g each)

Oxford Cem Implant

Semi-Permant Cement for Crowns and Bridges on Implants

IQ Dental

Iqdent CC Core Buildup 14G/14G Universal

REF Shade

3-OZ REF Shade 59 Tooth SHD Cold CU

SEcure®

SEcure® White Opaque Shade Resin Cement 9g Syringe (with 10 Tips)

SoloCem

6 catalogue numbers from 60013986, listed by Coltène/Whaledent AG, Switzerland, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Ortho-Choice™

Glass Ionomer Band Cement, 30 gm Powder, 15 mL liquid, scoop, mixing pad

Glass-FX Micro

Catalogue number GFX-MIC, listed by D.S.I Dental Solutions Ltd, under Cement, Dental. 3 manufacturers in China are registered for this product code.

IonoStar Plus

Fast-setting glass ionomer restorative material.

Embrace Wetbond Resin Cement

Medium Viscosity Automix Syringe Kit: 7 gm cement, 20 automix tips, 1.2 mL each Seal-n-Shine and OxOut, accessories Dual Cure, Fluoride Releasing, Radiopaque

Capo Flow a 4, 2 G

Catalogue number 234305, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

BruxZir

BruxZir™ Dual Cure Resin Cement

ClearTemp LC

ClearTemp LC Temporary Veneer Cement Refill

AHfILC

LC GI Rest Cem 15g/6ml A3.5

Complete Primer/Unfilled Resin

Catalogue number 654102, listed by Cosmedent, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

U/P Root Canal Powder

U/P Root Canal Powder, Bulk Small Set (1/2 oz powder, 1/4 oz liquid)

Hexa

Hexa Core , Dual Curing 3 in 1, Syr 6gm

PermaShade Try-In Paste

PermaShade Try-In Paste Opaque White Refill

Capo Flow C 3, 2 G

Catalogue number 234312, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Curaplex

BTM Emergency Dental KIT

Harmony Implant Cement

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

G-CEM LinkAce™

G-CEM LinkAce™ Translucent, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo

Temrex Powder

Powder FOR Mixing With Dental Cement Liquid

AuraVeneer Cement

AuraVeneer Cement. Kit of 4 x 1.2 ml Syringes. Shades: 1 Off White - 3 Opaque White

Harvard Temp Cem

3 catalogue numbers from 7081100, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AHfil+

Glass Ionomer Aesthetic Restorative A1

Harvard Polycarboxylat Cement, Single Powder, Shade 3

2 catalogue numbers from 7031503, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

ONE-Step 2ml Sample Package

Catalogue number U-1103P, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

C&B Base Natural 4g Syr

Catalogue number B-2213Q, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Geristore®

Geristor SY SMP A2 BAG 1FLW IT

OverCEM SA Starter Kit

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

Dentastic UNO

SINGLE COMPONENT DENTAL ADHESIVE, LIGHT CURE UNO Kit: 2 x 6 mL bottles Dentastic UNO, 5 mL etch gel, 20 APPLICATOR TIPS, 50 BRUSH TIPS, BRUSH HANDLE

TopCEM Vigor SA Self-Adhesive Resin Cement

TopCEM Vigor SA is a self-adhesive resin cement for fixing indirect dental restorations and posts. It cures through chemical polymerization and can also be activated by light. The base and…

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