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.

Glass-FX Bio

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

Durelon™ Maxicap™

3M™ ESPE™ Durelon™ Maxicap™ Carboxylate Luting Cement Refill, 56310

Metacem A1

2 catalogue numbers from 9405, listed by Meta Biomed Co., Ltd., South Korea, under Cement, Dental. 3 manufacturers in China are registered for this product code.

HY-Bond Polycarboxylate Temporary Cement

HY-Bond Poly Temp CEM 125/60

C&B (1 DualSyr) Nat w/FL

Catalogue number B-22310, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

SciPharm Glasion Glass Ionomer Liquid Bottle, Non-Boxed

Catalogue number SP 50-032, listed by Scientific Pharmaceuticals, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

ONE-Step Adhesive 2ml Sample

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

Capo Hybrid a 2, 5 G

Catalogue number 232021, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Henry Schein® Root Canal Liquid

Henry Schein® Root Canal Liquid, 3.5mL Bottle

Shatkin First Resin Cement Self-Cure

Shatkin First - An Advanced Eugenol Free Solution for Permanent Crown and Bridge Cementation. Resin Adhesive. 6-gram Dual Barrel. Boxed.

Vivid TempFil Pink/Hard

38gm

Impack

Impack Pink Fiber 1-LB

Systemp.desensitizer

Catalogue number 559596AN, listed by Ivoclar Vivadent Aktiengesellschaft, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Micron Luting

Micron Luting is a glass ionomer dental cement used to secure restorations and orthodontic components. Its indications include metal, porcelain fused to metal and resin crowns, bridges,…

Absolute

Absolute Translucent dental cement, 5ml syringe

Temp. Crown&Bridge KIT Chairside

Temp. Crown&Bridge KIT Charside

Interval II Plus

Self-Cured Dental Filling Material

NanoPaq C 2, 4 G

Catalogue number 234546, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq Flow a 3.5, 2 G

Catalogue number 234713, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

3m™

3M™ Delivery Tips With Pistons, 3303DT, 50ct

DeOx

DeOx Refill

Improv Temporary Implant Cement by Salvin Dental Specialties

Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge Restorations.

Capo Hybrid a 1, 5 G

Catalogue number 232020, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

TempoCemID

Temporary cement smartmix system. Invisible under restorations, yet detectable for excess removal. Content: 1 syringe @ 5ml, Accessories.

Capo Hybrid a 3, 0.3 G

Catalogue number 232122, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq B 3, 0.3 G

Catalogue number 234617, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural C 3, 4 G

Catalogue number 232048, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Bifix Temp

Bifix Temp is a dual-curing, composite-based temporary luting material.

Pearl Composite Luting Cement Auto-Mix System, Single Carthridge

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…

DuoTEMP

3 catalogue numbers from 5831, listed by Coltène/Whaledent AG, Switzerland, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Anchor 25ml Cartridge Refill Kit Shade A2

Anchor 25ml Cartridge Refill Kit Shade A2: 1 catalogue number listed by Vista Dental, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Nexus Universal Refill Kit-Clear With Chroma

Nexus Universal Clear with Chroma Syringe, Automix Tips (Wide and Regular)

Micron Dentin Conditioner

Micron Dentin Conditioner prepares dentin before placement of a glass ionomer cement restoration. It is a mild polyacrylic acid solution that removes the dentinal smear layer and conditions…

Implantlink Temporary Implant Cement

Implantlink Temporary Cement

Aladdin™ Flow Flowable Composite

Aladdin™ Flow Syringe Refill Package - A3.5 (2 x 1.3g, 30 Tips)

Improv Temporary Implant Cement by Dentegris Dental Implant System

Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge Restorations.

Pearl Composite Luting Cement Syringe System, Part B Single Syringe

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…

Provicol QM

3 catalogue numbers from 1109, listed by Voco Gmbh, Germany, under Cement, Dental. 3 manufacturers in China are registered for this product code.

GlassLine™ Kit

30 gm Powder, 15 mL liquid, scoop, mixing pad

Harvard Polycarboxylat Cement, Single Liquid

Catalogue number 7031600, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

One-Step

One-Step 4ml Bottle Pkg

Orapro

Orthqst Orapro LC Band CEM Blue 1-5G KIT

Harvard Ionoresin Fill OptiCaps A3

Catalogue number 7071251, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Nexus Universal Refill Kit – Yellow

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

Protech

Glass Ionomer Band Cement Introductory Kit

Uptemp by 3d Dental

Uptemp Temporary Cement Automix Syringe 7 ML NE

NoMix

NoMix 1g temporary cement syringe, 6 pk

Pearson Polycarboxylate Cement

Catalogue number A590008, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Provicol

Eugenol-free temporary luting cement with calcium hydroxide. Semi-elastic properties for safe adhesion of the temporary. Calcium hydroxide: supports formation of secondary dentine and is…

Bosworth

Zinc Phosphate Dental Cement P&L Standard Kit Lt Yellow

Rock Cement

All ceramic self-adhesive Resin cement

IP-TempCement

IP Temp Cement Capsules (50Pcs)

OSE

Zinc Phosphate Cement Powder

Zirconomer P

ZIRCONOMER P CAPSULE Universal Shade 3pcs (Sample)

PermaCem Smartmix Dual

Permanent luting cement automix system. The highlight of restorations. Content: 2 syringes @ 10 g paste, Accessories

Vivid SilverCem

15g pdr/ 7ml liq

Maxcem Elite Chroma

Universal Resin Cement with Cleanup Indicator. Syringes, 4:1 Automix Tips (Regular, Wide) and Intraoral Tips

NanoPaq a 1, 4 G

Catalogue number 234510, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

IonoStar Molar

Glas ionomer restorative material in three different shades.

Clearfil™ SE Bond 2

Unit Dose Trial Pack

Cimpat Pink

Temporary filling material

Anchor 25ml Cartridge Kit Shade A2

Anchor 25ml Cartridge Kit Shade A2: 1 catalogue number listed by Vista Dental, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Flow B 2, 2 G

Catalogue number 234307, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Ceramir Bioceramic Implant Cement QuikCap

Catalogue number 40037, listed by Doxa Dental AB, Sweden, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Slow Flow Capsules a 2, 20 X 0.25

Catalogue number 232113, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Slow Flow B 1, 2 G

Catalogue number 232065, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

GC Fuji Varnish™

GC Fuji VARNISH™ 10 g liquid

RelyX™ Unicem 2 Clicker™

3M™ ESPE™ RelyX™ Unicem 2 Self-Adhesive Resin Cement - Clicker Refill - Translucent, 56874

Interval

Dental Filling Material

AHL Generic

G.I Luting Cement Liquid 15ml

Granitec Blue Band Cement Light Cure 5g

Catalogue number FP-NOVOINC-057, listed by Septodont, Inc, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Integrity® TempGrip® Temporary Crown & Bridge Cement

Integrity® TempGrip® Temporary Crown & Bridge Cement Syringe Refill Package

Olympian M Temporary Cement Auto-Mix System Single Carthridge

Catalogue number 0001, listed by Dent ZAR, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq Fillis Set

Catalogue number 234600, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Telio CS Inlay Telio CS Onlay

Telio CS Inlay Refill 30x0.25g Universal

IRM® Intermediate Restorative Material

IRM® Intermediate Restorative Material, Ivory, Standard Package

Harvard Ionoresin Fill OptiCaps A2

2 catalogue numbers from 17727, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Cerec® Essentials With Celtra® Duo (ZLS) Blocks

CEREC® Essentials Combo Kit with Celtra® Duo (ZLS) Blocks

TempoCem®NE Automix

Temporary cement automix system, eugenol free. The temporary cement that keeps its promise. Content: 1 cartridge @ 25 ml paste, accessories.

Pearson Glass Ionomer Silver Rein

Catalogue number A590012, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Harvard Implant Semi-Permanent

Dual cure semi-permanent luting cement

Harvard Ionoglas Fill Extra A3

Catalogue number 7052113, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Slow Flow a 3.5, 2 G

Catalogue number 232064, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Ketac™ Silver Maxicap™

3M™ ESPE™ Ketac™ Silver Maxicap™ Silver Reinforced Glass Ionomer Restorative, 50 Capsules 56210

PIC

Premier Implant Cement Value Pack

Nexus Universal Automix Tips – Regular

Automix Tips

Speedcem 100

Speedcem 100 Refill 1x9g transparent

FL-Bond II

FL Bond II Etchant

3g Bulk Fill Composite C2 Syringe

Catalogue number H-931C2, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Metacem Kit

Catalogue number 9215, listed by Meta Biomed Co., Ltd., South Korea, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Harvard Polycarboxylat Cement, Clinic Powder, Shade 3

2 catalogue numbers from 7031203, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

AxioCem Conditioner

Catalogue number 24005, listed by Axiodent Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Hybrid B 2, 5 G

Catalogue number 232024, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Cement, Dental

‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND®

Embrace Wetbond Resin Cement – Dual Cure, Fluoride Releasing, Radiopaque

Medium Viscosity Automix Syringe Refill: 7 gm cement, 20 automix tips

Multilink Hybrid Abutment

Multilink Hybrid Abutment Refill HO 0

GC Fuji Temp LT™

GC Fuji TEMP LT™ Introductory Kit (2 x Paste Pak Cartridge 13.3g (7.2mL), 1 x mixing pad & 1 x GC Paste Pak Dispenser)

C&B Metabond®

‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND®

Repair Liquid

Repair Liquid 1 Quart

Temrex CR

Catalogue number 7780, listed by Temrex Corp., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Oxford GI Resin CEM UF Handmix

Light Cure Ultra Fine Resin Modified Glass Ionomer Cement for Luting

Nexus Universal Refill Kit – White Opaque

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

GIaslonomer Set

Glas CEM Type II UNI 15G/8ML

Systemp.link

Catalogue number 576870AN, listed by Ivoclar Vivadent Aktiengesellschaft, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Riva Bond

Riva Bond LC P/L KT

Provisa

Provisa CEM GI Perm Cement BX50

GoldLink

Goldlink 2 KIT

3m™ Ketac™ Fil Plus Aplicap™

3M™ Ketac™ Fil Plus Aplicap™ Glass Ionomer Filling Material Shade A2, Light Yellow, 55023

AHlute Ortho

Ortho G.I W/Mix 30g Pdr

BisCem

BisCem Translucent 8g Dual Syringe Pkg

International Dental Supply Until Temporary Crown and Bridge Cement

Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Italian.

Refilit

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

Smart Advantage GI A2 Ampoule

Catalogue number 575CAPA2S, listed by Elevate Oral Care, LLC, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Midway Select

Midway Select Temporary Cement NE

Harvard Ionoglas Fill Extra OptiCaps A3

Catalogue number 7052253, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Meron Plus AC

Resin reinforced glass ionomer luting cement.

NexTemp Clear

NexTemp Clear Standard Pack One 5ml syringe and Ten mix-tips

NanoPaq a 3.5, 0.3 G

Catalogue number 234613, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NuSmile BioCem

NuSmile BioCem 5.0ml Extra Light Shade Kit, Blue Automix Tips (25 cnt)

Stabiliner

Stabiliner Standard SET Intro KIT 1 Cart AND 10 Kits Brown Mixers 20 PER Case (HS Part # 9973204)

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