Disk, Abrasive

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, based in Shanghai and Hebei. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Huanghua Promisee Dental Co., Ltd. Hebei
Shanghai Dochem Industries Co., Ltd. Shanghai
Shanghai Shofu Dental Material Co., Ltd. Shanghai
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai, contract manufacturer

What Is FDA Product Code EHJ?

Disk, Abrasive is FDA product code EHJ, Class 1, 21 CFR 872.6010.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2016. None was by a company in China. The root cause the FDA records most often is Process control (1).

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

Asap All Surface Access Polishers Indirect Intraoral Cylinder Adjuster Refill

Catalogue number 130923, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

SeptoDiscs Mandrel Refill: 1 Mandrel Pop

Mandrel for contra angle

FlexiDisc Mini 3/8 Medium

Catalogue number 402238, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiBuff Mini 5/8

Catalogue number 402658, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Intra Oral Polisher Medium Disc

Catalogue number 414012, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 3/8 Coarse

Catalogue number 402138, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® All Surface Access Polishers 6-Pack Refill (Small)

2 catalogue numbers from 130913, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini Assort Pack 5/8

Catalogue number 4025CS, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 5/8 Coarse

Catalogue number 402158, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Bulk Pack Large Final High Shine Polisher

Catalogue number 130926, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Diamond Polishing Brushes & Wheel System Kit

Catalogue number 133155, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

SeptoDiscs Kit: 120 Assorted Abrasive Discs+ Mandrel Pop-on

Catalogue number 01C4001, listed by Septodont SAS Specialites Septodont, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® All Surface Access Polishers Promotional Pack

Catalogue number 971302, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 5/8 Medium

Catalogue number 402258, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Regular 3/4 Medium

Catalogue number 401234, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Indirect+ Extraoral/HP Disc Adjuster Refill

Catalogue number 130945, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Regular 3/4 Coarse

Catalogue number 401134, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini Assort Pack 1/2 5/8

Catalogue number 402DISC, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

SeptoDiscs Refill: 1/2” 50 Coarse Abrasive Discs

Catalogue number 01C4003, listed by Septodont SAS Specialites Septodont, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Indirect+ Extraoral/HP Pre-Polisher Refill

Catalogue number 130942, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Diamond Polishing Brushes Pre-Polisher Refill 3-Pack

Catalogue number 133156, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Dailies Diamond Polishers

Catalogue number 970133, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Contours™ Finishing & Polishing Discs 1/2″ Starter Kit

Catalogue number 133001, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Diamond Polishing Brushes Final Polisher Refill 3-Pack

Catalogue number 133157, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Indirect+ Extraoral/HP Polisher Refill

Catalogue number 130941, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Two Striper

Diamond Finishing Disc

Enhance® Finishing System/Enhance® PoGo® Polishing System

Enhance Finishing System/Enhance PoGo Polishing System Evaluator Package

Diatemp HP Wheel, Pu: 6 Pcs HC

2 catalogue numbers from 240HP, listed by Diaswiss SA, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 1/2 Fine

Catalogue number 402312, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

SeptoDiscs Refill: 1/2” 50 Assorted Abrasive Discs

Catalogue number 01C4002, listed by Septodont SAS Specialites Septodont, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Indirect+ Extraoral/HP Polisher Refill

Catalogue number 130941, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p. Bulk Pack Large Pre-Polishers

Catalogue number 130928, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc 5/8 Fine

Catalogue number 401358, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Contours™ Finishing & Polishing Discs Sample Kit

Catalogue number 972002, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Intra Oral Polisher Superfine Disc

Catalogue number 414007, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 5/8 Coarse Sand

Catalogue number 402588, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Diaswiss Felt, Pu: 12 Pcs

Catalogue number 260RA, listed by Diaswiss SA, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® All Surface Access Polishers Assorted Starter Pack

Catalogue number 130917, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Diamond Polishing Brushes 6-Pack

Catalogue number 133158, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini Starter Kit 5/8

Catalogue number 402058, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Indirect+ Extraoral/HP Starter Kit

Catalogue number 130940, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Zubler USA

Chairside rotary tool adjustment kit for crowns. Kit contains discs (LXZW), points (NCFW), and burs (HGDH)

A.s.a.p.® Dailies 50-Pack

Catalogue number 133160, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 5/8 Fine

Catalogue number 402358, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiBrush Cup Shape

Catalogue number 404201, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Regular 1/2 Medium

Catalogue number 401212, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® All Surface Access Polishers Assorted Starter Pack

Catalogue number 130917, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Malibu Pincuttersalibu Roughing

100 Malibu Pincutters Discs 35X1.7MM

FlexiBuff Mini 3/8

Catalogue number 402638, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Diatemp HC

Catalogue number 230HP-0, listed by Diaswiss SA, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Malibu Pincutters

100 Malibu Pincutters 40MMX1MM

SeptoDiscs Refill: 1/2” – 50 Extra Fine Abrasive Discs

Catalogue number 01C4006, listed by Septodont SAS Specialites Septodont, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Indirect+ Extraoral/HP Pre-Polisher Refill

Catalogue number 130942, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® Bulk Pack Large Pre-Polishers

Catalogue number 130928, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Diaceram 2-Step

2 catalogue numbers from 112RA-0, listed by Diaswiss SA, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini Starter Kit 3/8

Catalogue number 402038, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p. Bulk Pack Large Final High Shine Polisher

Catalogue number 130926, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiBuff Regular 5/8

Catalogue number 401658, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Contours™ Finishing & Polishing Discs Mandrel Kit Refill Pack

Catalogue number 133012, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Cutoff Disks

Catalogue number 0441, listed by Shofu Dental Corp., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc 1/2 Superfine

Catalogue number 401412, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 3/8 Fine

Catalogue number 402338, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini Starter Kit 1/2

Catalogue number 402012, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Contours™ Finishing & Polishing Discs 3/8″ Starter Kit

Catalogue number 133002, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

FlexiDisc Mini 5/8 Extrafine Garnet

Catalogue number 402XFG, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® All Surface Access Polishers Trial Kit (Small)

Catalogue number 130910, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Diacomp Lense, Pu: 6 Pcs

Catalogue number 192RA, listed by Diaswiss SA, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

A.s.a.p.® All Surface Access Polishers 6-Pack Refill (Large)

2 catalogue numbers from 130912, listed by Clinician'S Choice Dental Products, Inc., Canada, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Contours™ Finishing & Polishing Discs 1/2″ Starter Kit

Catalogue number 133001, listed by DEN-MAT Holdings, LLC, United States, under Disk, Abrasive. 4 manufacturers in China are registered for this product code.

Brownie

HP Brownie Floppie

FlexiDisc 5/8 Superfine

Catalogue number 401458, listed by Cosmedent, Inc., United States, under Disk, Abrasive. 4 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