Consulting Wallah › Device Explorer › Dental › Ceramic dental bur
Device Explorer · FDA GUDID · GMDN 63630

Ceramic dental bur

A rotary cutting device, the working end of which is made from ceramic, designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. It is available in various shapes (e.g., c

US‑registered devices53in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Gebr. Brasseler Gmbh & Co. Kg3668%
Sds Swiss Dental Solutions Ag1630%
Rønvig Dental Manufacturing A/S12%

Top labelers

CompanyDevicesShare
Gebr. Brasseler Gmbh & Co. Kg3668%
Sds Swiss Dental Solutions Ag1630%
Rønvig Dental Manufacturing A/S12%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CTT CERAMIC TISSUE TRIMMERSDS1.2/ SDS2.2KOMET Dental Ceramic BursKOMET CeraDrillKOMET Surgical Bur

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

FDA product codes

CodeNameDevices
EJLBUR, DENTAL30
NDPAccessories, Implant, Dental, Endosseous16
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY6
DZADrill, Dental, Intraoral1

GMDN & GCC registration

  • GMDN code 63630 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 98% · OTC 2%
  • 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 ceramic dental bur products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ceramic dental bur", from 3 companies. The largest labeler is Gebr. Brasseler Gmbh & Co. Kg with 68% of records.

Which FDA product codes apply?

EJL (BUR, DENTAL), NDP (Accessories, Implant, Dental, Endosseous), GFF (BUR, SURGICAL, GENERAL & PLASTIC SURGERY), DZA (Drill, Dental, Intraoral)

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.

How do I get quotes?

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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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