Consulting Wallah › Device Explorer › Dental › Fixture/appliance dental drill bit, reusable
Device Explorer · FDA GUDID · GMDN 45714

Fixture/appliance dental drill bit, reusable

A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of gradu

US‑registered devices14,938in commercial distribution
Companies89labelers on GUDID
Single‑use10%of device records
Sterile4%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Osstem Implant Co., Ltd.2,60517%
Megagen Implant Co. Ltd1,3579%
Innobiosurg Co.,Ltd(Ibs Implant Co.,Ltd)9006%
Neobiotech. Co., Ltd6855%
Dio Corporation5404%
Jjgc Indústria E Comércio De Materiais Dentários S/A.4693%
Adin Dental Implant Systems Ltd4443%
Dentsply Implants Manufacturing Gmbh4043%

Top labelers

CompanyDevicesShare
Osstem Implant Co., Ltd.2,60517%
Megagen Implant Co. Ltd1,3579%
Innobiosurg Co.,Ltd(Ibs Implant Co.,Ltd)9006%
Neobiotech. Co., Ltd6855%
Dio Corporation5404%
Jjgc Indústria E Comércio De Materiais Dentários S/A.4693%
Adin Dental Implant Systems Ltd4443%
Dentsply Implants Manufacturing Gmbh4043%
Ossvis Co., Ltd.3863%
Altatec Gmbh3702%
Southern Implants (Pty) Ltd3642%
Zimvie Us Corp Llc3422%

Company = labeler of record on GUDID. 89 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DS ImplantsDS PrimeTaperDS Prime TaperDS OmniTaperFRIOS®XiVE®ANKYLOS®SIMPLANT®Astra Tech Implant System®Nobel Biocare N1™Nobel Biocare®NobelReplace®Brånemark System®NANobelZygoma™ TiUltra™Twist drill

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

FDA product codes

CodeNameDevices
DZADrill, Dental, Intraoral6,761
NDPAccessories, Implant, Dental, Endosseous4,205
NDPAccessories, implant, dental, endosseous1,532
EJLBur, Dental831
DZADRILL, DENTAL, INTRAORAL719
EBLPin, Retentive And Splinting, And Accessory Instruments264

GMDN & GCC registration

  • GMDN code 45714 · non‑implantable
  • Single‑use 10% · sterile 4% · Rx‑only 80% · 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) · 1,470Length (Millimeter) · 1,070Height (Millimeter) · 25Lumen/Inner Diameter (Millimeter) · 16Width (Millimeter) · 3Angle (degree) · 1

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

How many fixture/appliance dental drill bit, reusable products are registered in the US?

14,938 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fixture/appliance dental drill bit, reusable", from 89 companies. The largest labeler is Osstem Implant Co., Ltd. with 17% of records.

Which FDA product codes apply?

DZA (Drill, Dental, Intraoral), NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), 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.

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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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