Consulting Wallah › Device Explorer › Dental › Carbide dental bur, reusable
Device Explorer · FDA GUDID · GMDN 16668

Carbide dental bur, reusable

A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.

US‑registered devices12,753in commercial distribution
Companies68labelers on GUDID
Single‑use10%of device records
Sterile8%labelled sterile
Prescription50%Rx‑only share
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Share of device records

M.D.T. - Micro Diamond Technologies Ltd.1,79514%
Peter Brasseler Holdings, Llc1,55512%
Edenta Etablissement1,23510%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung8677%
Gebr. Brasseler Gmbh & Co. Kg7306%
Coltene/Whaledent Inc5785%
Beyes Dental Canada Inc5094%
Henry Schein, Inc.4764%

Top labelers

CompanyDevicesShare
M.D.T. - Micro Diamond Technologies Ltd.1,79514%
Peter Brasseler Holdings, Llc1,55512%
Edenta Etablissement1,23510%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung8677%
Gebr. Brasseler Gmbh & Co. Kg7306%
Coltene/Whaledent Inc5785%
Beyes Dental Canada Inc5094%
Henry Schein, Inc.4764%
Jota Ag3723%
Prima Dental Manufacturing Limited3503%
Dfs - Diamon Gmbh3433%
Nti - Kahla Gmbh Rotary Dental Instruments3223%

Company = labeler of record on GUDID. 68 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Edge™ Carbide Burs KT 245T Katana Carbide BurEdge™ Carbide BursFG 9904 Needle Gold Carbide BuEdge™ Carbide Burs FG 9714 Taper Pointed Gold CaEdge™ Carbide Burs FG 9642 Taper Round End Gold Edge™ Carbide Burs FG 9406 Egg Gold Carbide BurEdge™ Carbide Burs EF9 Gold Carbide BurEdge™ Carbide Burs FG 7901 Needle Gold Carbide BEdge™ Carbide Burs FG 7702 Taper Flat Gold CarbiEdge™ Carbide Burs FG 7675 Taper Round End Gold Edge™ Carbide Burs FG 7642 Taper Round End Gold Edge™ Carbide Burs FG 7408 Egg Gold Carbide BurEdge™ Carbide Burs FG 7404 Egg Gold Carbide BurEdge™ Carbide Burs FG 7303 Pear Gold Carbide BurEdge™ Carbide Burs FG 7214 Taper Pointed Gold CaEdge™ Carbide Burs FG 7114 Taper Pointed Gold CaEdge™ Carbide Burs FG 7106 Flame Gold Carbide Bu

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

FDA product codes

CodeNameDevices
EJLBUR, DENTAL10,450
EJLBur, Dental3,155
DZADrill, Dental, Intraoral284
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY143
GFFBur, Surgical, General & Plastic Surgery56
HTTBurr, Orthopedic22

GMDN & GCC registration

  • GMDN code 16668 · non‑implantable
  • Single‑use 10% · sterile 8% · Rx‑only 50% · 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

Outer Diameter (Millimeter) · 66Length (Millimeter) · 2

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

How many carbide dental bur, reusable products are registered in the US?

12,753 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Carbide dental bur, reusable", from 68 companies. The largest labeler is M.D.T. - Micro Diamond Technologies Ltd. with 14% of records.

Which FDA product codes apply?

EJL (BUR, DENTAL), EJL (Bur, Dental), DZA (Drill, Dental, Intraoral), GFF (BUR, SURGICAL, GENERAL & PLASTIC SURGERY)

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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