Consulting Wallah › Device Explorer › Dental › Dental abrasive point, single-use
Device Explorer · FDA GUDID · GMDN 63517

Dental abrasive point, single-use

A sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g.,

US‑registered devices184in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile12%labelled sterile
Prescription18%Rx‑only share
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Share of device records

Ss White Burs, Inc.13473%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung3217%
Plasdent Corporation63%
Young Innovations, Inc.53%
The Atlanta Dental Supply Company42%
Darby Dental Supply, Llc21%
Micerium Spa11%

Top labelers

CompanyDevicesShare
Ss White Burs, Inc.13473%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung3217%
Plasdent Corporation63%
Young Innovations, Inc.53%
The Atlanta Dental Supply Company42%
Darby Dental Supply, Llc21%
Micerium Spa11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ena Shinyn/aDarby Dental Supply, LLCPlasdentJohnson-PromidentDefendJAZZ POLISHERAdvance Dental Products

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

FDA product codes

CodeNameDevices
EHLPOINT, ABRASIVE157
EHMSTRIP, POLISHING AGENT18
EJQWheel, Polishing Agent7
EHJDisk, Abrasive7
NRDUnit, Operative Dental, Accessories6
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY2

GMDN & GCC registration

  • GMDN code 63517 · non‑implantable
  • Single‑use 100% · sterile 12% · Rx‑only 18% · OTC 0%
  • 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 point, single-use products are registered in the US?

184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental abrasive point, single-use", from 7 companies. The largest labeler is Ss White Burs, Inc. with 73% of records.

Which FDA product codes apply?

EHL (POINT, ABRASIVE), EHM (STRIP, POLISHING AGENT), EJQ (Wheel, Polishing Agent), EHJ (Disk, Abrasive)

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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