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Device Explorer · FDA GUDID · GMDN 34816

Dental laboratory bur

A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, a hard material (e.g., particles of diamond or tungsten carbide), and which is designed to fit into a dental laboratory handpiece that provides the rotatio

US‑registered devices652in commercial distribution
Companies6labelers on GUDID
Single‑use14%of device records
Sterile0%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Edenta Etablissement27442%
Ss White Burs, Inc.20331%
Nti - Kahla Gmbh Rotary Dental Instruments11317%
Trirock Dental Llc305%
Ace Surgical Supply Co., Inc.193%
Peter Brasseler Holdings, Llc132%

Top labelers

CompanyDevicesShare
Edenta Etablissement27442%
Ss White Burs, Inc.20331%
Nti - Kahla Gmbh Rotary Dental Instruments11317%
Trirock Dental Llc305%
Ace Surgical Supply Co., Inc.193%
Peter Brasseler Holdings, Llc132%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EDENTANTIBrasseler USAEXPRESS LINE DIAMONDSSW CARBIDE CAD CAMSSW CARBIDE GREATE WHITE LAB CUTTERSTriRock DentalACE

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

FDA product codes

CodeNameDevices
DZPINSTRUMENT, DIAMOND, DENTAL421
EJLBUR, DENTAL229
FRGWrap, sterilization2

GMDN & GCC registration

  • GMDN code 34816 · non‑implantable
  • Single‑use 14% · sterile 0% · Rx‑only 5% · 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) · 19

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

How many dental laboratory bur products are registered in the US?

652 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental laboratory bur", from 6 companies. The largest labeler is Edenta Etablissement with 42% of records.

Which FDA product codes apply?

DZP (INSTRUMENT, DIAMOND, DENTAL), EJL (BUR, DENTAL), FRG (Wrap, sterilization)

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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