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Device Explorer · FDA GUDID · GMDN 16669

Steel dental bur, reusable

A rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structure

US‑registered devices2,757in commercial distribution
Companies43labelers on GUDID
Single‑use20%of device records
Sterile2%labelled sterile
Prescription45%Rx‑only share
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Share of device records

Frontier Dental Supply Inc45216%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung39014%
Soadco, S.L.28510%
Mig Tools Industria E Comercio Ltda2208%
Icp, Inc.1987%
Edenta Etablissement1746%
Jota Ag1265%
Aira, Llc984%

Top labelers

CompanyDevicesShare
Frontier Dental Supply Inc45216%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung39014%
Soadco, S.L.28510%
Mig Tools Industria E Comercio Ltda2208%
Icp, Inc.1987%
Edenta Etablissement1746%
Jota Ag1265%
Aira, Llc984%
Talladium España Sl703%
Zimvie Us Corp Llc652%
Busch & Co. Gmbh & Co. Kg612%
Ceramtec Schweiz Gmbh552%

Company = labeler of record on GUDID. 43 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

XiVE®ANKYLOS®SurtexLuscent-RConical / Tapered ReamersPathfinder RoutersProbos II Reamers / RoutersClassic Standard ReamersTwin LuscentLuscentOsseoComp Bur NC L3.4(4.0)4.6mmDOsseoComp Bur NC L2.8(3.4)4.0mmDOsseoComp Bur NC L2.2(2.8)3.4mmDOsseoComp Bur NC L1.6(2.2)2.8mmDSinLift Bur NC S4.6(4.9)5.2mmDSinLift Bur NC L4.2(4.5)4.8mmD

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

FDA product codes

CodeNameDevices
EJLBur, Dental1,165
EJLBUR, DENTAL926
NDPAccessories, implant, dental, endosseous389
NDPAccessories, Implant, Dental, Endosseous206
GFFBur, Surgical, General & Plastic Surgery59
DZADrill, Dental, Intraoral38

GMDN & GCC registration

  • GMDN code 16669 · non‑implantable
  • Single‑use 20% · sterile 2% · Rx‑only 45% · OTC 7%
  • 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) · 86Length (Millimeter) · 22

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

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

2,757 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Steel dental bur, reusable", from 43 companies. The largest labeler is Frontier Dental Supply Inc with 16% of records.

Which FDA product codes apply?

EJL (Bur, Dental), EJL (BUR, DENTAL), NDP (Accessories, implant, dental, endosseous), NDP (Accessories, Implant, Dental, Endosseous)

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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