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Device Explorer · FDA GUDID · GMDN 64617

Dental abrasive disk, single-use

A dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing denta

US‑registered devices230in commercial distribution
Companies18labelers on GUDID
Single‑use92%of device records
Sterile1%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Cosmedent, Inc.6327%
Tdv Dental Ltda5926%
3M Company209%
Plasdent Corporation146%
Premier Dental Products Company136%
Edenta Etablissement104%
Busch & Co. Gmbh & Co. Kg104%
Peter Brasseler Holdings, Llc104%

Top labelers

CompanyDevicesShare
Cosmedent, Inc.6327%
Tdv Dental Ltda5926%
3M Company209%
Plasdent Corporation146%
Premier Dental Products Company136%
Edenta Etablissement104%
Busch & Co. Gmbh & Co. Kg104%
Peter Brasseler Holdings, Llc104%
Young Innovations, Inc.83%
Septodont Sas Specialites Septodont73%
Micerium Spa52%
Jordco Inc31%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ena ShinySUPER-SNAPEDENTADarby Dental Supply, LLCPure Buff KitPure BuffPlasdentZubler USAJohnson-PromidentThe Orthodontic StorePreatBUSCH®, BNA®FlexiSawFlexiDiamond Strips Narrow CoarseFlexiDiamond Strips Narrow MediumFlexiDiamond Strips Narrow Superfine

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EHJDisk, Abrasive124
EHJDISK, ABRASIVE34
EHLPOINT, ABRASIVE17
NRDUnit, Operative Dental, Accessories14
EHMStrip, Polishing Agent13
EJQWHEEL, POLISHING AGENT11

GMDN & GCC registration

  • GMDN code 64617 · non‑implantable
  • Single‑use 92% · sterile 1% · Rx‑only 52% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many dental abrasive disk, single-use products are registered in the US?

230 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental abrasive disk, single-use", from 18 companies. The largest labeler is Cosmedent, Inc. with 27% of records.

Which FDA product codes apply?

EHJ (Disk, Abrasive), EHJ (DISK, ABRASIVE), EHL (POINT, ABRASIVE), NRD (Unit, Operative Dental, Accessories)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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