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.

AHlute

G.I Luting Cement 15g/7ml

Panavia SA Cement Universal

Panavia SA Cement Universal Handmix is a self-adhesive dental resin cement for securing restorations. Its uses include crowns, bridges, inlays, onlays, posts and cores, as well as…

Vivid Temp Cem NE

Catalogue number D440698, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Glisten™ Provisional Resin Glaze

Provisional Resin Glaze

3m™ Ketac™ Cem Aplicap™

3M™ Ketac™ Cem Aplicap™ Capsule Permanent Glass Ionomer Luting Cement Refill NA, 56061

Capo Slow Flow B 3, 2 G

Catalogue number 232067, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Calibra® Cement

Calibra® Cement Automix Syringe Mixing Tip Refill

TempoLok NE Cement 118g Cartridge, 50 Mixing Tips

The TempoLok™ Automix NE refill includes: one double cartridge (118 g) non-eugenol, zinc oxide cement and 50 mixing tips. This product is used for temporary cement for attaching all kinds…

Capo Slow Flow a 3, 2 G

Catalogue number 232063, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Hybrid B 3, 5 G

Catalogue number 232025, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Vivid Core Cem Powder

Catalogue number A590038, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

TimeLine™ Visible Light Cure Base/Liner Composition

TimeLine® Visible Light Cure Base/Liner Composition Refill Package, 1 tube (4g)

Harvard Ionoresin Fill OptiCaps A3,5

Catalogue number 7071252, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Harvard Cement Quick Setting, Single Liquid

Catalogue number 7001600, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

C&B 2 Syr X 4g Pkg – Nat w/FL

Catalogue number B-2400NF, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Vanish™ XT

3M™ ESPE™ Vanish™ XT Extended Contact, 12158

Fixtemp Cement

Catalogue number D503931, listed by Dreve Dentamid Gmbh, Germany, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Natural a 1, 4 G

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques

DT Light Post System Kit

Catalogue number G-91320K, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Metaltite

Catalogue number 16547, listed by Tokuyama Dental Corporation, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Burkhart Non-Eugenol Temporary Cement Automix Syringe 5ml

Catalogue number 72722200, listed by Burkhart Dental Supply Co., THE, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Zinc Oxide Eugenol(ZOE) Temporary Cement Kit

HY-Bond ZOE Temp Cement KIT

Scott’s Select Automix 25ml Temp Cement NE

Catalogue number 199-1008, listed by Scott's Dental Supply L.L.C., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Oxford GI Resin CEM UF Capsules

Light Cure Ultra Fine Resin Modified Glass Ionomer Cement for Luting

CXPlus

CX-Plus Capsules

Cimpat White

Temporary filling material

Vivid TempCem Plus Standard Package

Catalogue number D440700, listed by Pearson Dental Supplies, Inc., under Cement, Dental. 3 manufacturers in China are registered for this product code.

Anchor 5ml Syringe Shade White Opaque

Anchor 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.

NanoPaq a 2, 0.3 G

Catalogue number 234611, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Pearl Composite Luting Cement Auto-Mix 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…

Pearson Polycarboxylate Cement Triple Powder

60 gm

NanoPaq a 3.5, 4 G

Catalogue number 234513, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Cling2® Resin Optimized Temporary Cement 5ml Syringe

Catalogue number 158900, listed by DEN-MAT Holdings, LLC, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Scott’s Select Glass Ionomer Plus STD KIT

Catalogue number 199-1003, listed by Scott's Dental Supply L.L.C., under Cement, Dental. 3 manufacturers in China are registered for this product code.

VisCalor

VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Futurabond U

Smart Advantage GI Sample A1 and A2 Pk

Catalogue number 675UD0200, listed by Elevate Oral Care, LLC, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

C&B (1 DualSyr) Pkg – Nat w/FL

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

Harvard Ionoglas Fill A2

Classical glass ionomer restorative cement

E.T.C.™

E.T.C.™ Easy Temporary Cement

Harvard Ionoresin Fill A3

Catalogue number 7071116, listed by Harvard Dental International GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Bisico Glass Cem

Glass ionomer luting cement, suitable for cementing crowns, bridges, inlays and onlays. Is used in dentistry.

Flexi-Flow Natural

Post Cement Paste/Paste Chemical Cure Natural Shade A3

Harvard Ionoresin Cem, Shade Universal

Resin modified glass ionomer cement for luting and lining, light cure

HY-Bond Polycarboxylate Cement

HY-Bond Poly KIT

Bulk Fill Composite Unit Dose (C2) – 25

Catalogue number H-9332C2, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

GC Ceramic Primer II

2 catalogue numbers from 008551, listed by GC America Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Porelain Primer

Porcelain Primer

Nexus Universal Sample – Clear

Syringe (Clear), Automix Tips

Repair Powder

Repair Powder Clear 7 LB

Bulk Fill Composite C2 Syringe Pkg

Catalogue number H-931C2P, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NanoPaq a 3, 4 G

Catalogue number 234512, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

TFilEco

Temp Filling Mat Eco 35g Jar

AxioCem Type II

Catalogue number 24002, listed by Axiodent Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Capo Flow a 2, 2 G

Catalogue number 234302, listed by Schütz Dental GmbH, under Cement, Dental. 3 manufacturers in China are registered for this product code.

OverCEM Cer-Abutment Starter Kit

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

StarDental Instrument Solutions

RC Cement-Non Stain Kit

Biscem Translucent 1g Smpl

Catalogue number D-45001S, listed by Bisco, Inc., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

NeoPRO™

NeoPRO™ Bioceramic Sealer 0

Oxford GI Resin Prime VLC

Primer for Resin Modified Glass Ionomer Cement

Anchor 25ml Cartridge Refill Kit Shade White Opaque

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

Neobond

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

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