Consulting Wallah › Device Explorer › Dental › Titanium dental bur
Device Explorer · FDA GUDID · GMDN 46621

Titanium dental bur

A rotary cutting device, the working end of which is made from titanium (Ti), and which is 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 can also be used to

US‑registered devices68in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Ace Surgical Supply Co., Inc.5885%
Biotechnology Institute Sl812%
Bicon, Llc23%

Top labelers

CompanyDevicesShare
Ace Surgical Supply Co., Inc.5885%
Biotechnology Institute Sl812%
Bicon, Llc23%

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

Brand names on the register (sample)

TrephineACECOMPACTOR DRILL NR.4COMPACTOR DRILL NR.3COMPACTOR DRILL NR.2COMPACTOR DRILL NR.1OSTEOTOME DRILL N.4OSTEOTOME DRILL N.3OSTEOTOME DRILL N.2OSTEOTOME DRILL N.1

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

FDA product codes

CodeNameDevices
HWKTREPHINE56
EJLBur, Dental10
EJLBUR, DENTAL2

GMDN & GCC registration

  • GMDN code 46621 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · 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) · 58

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

No closely related category with 50+ devices.

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

68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Titanium dental bur", from 3 companies. The largest labeler is Ace Surgical Supply Co., Inc. with 85% of records.

Which FDA product codes apply?

HWK (TREPHINE), EJL (Bur, Dental), EJL (BUR, DENTAL)

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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