Consulting Wallah › Device Explorer › Dental › Fixture/appliance dental drill bit, single-use
Device Explorer · FDA GUDID · GMDN 45697

Fixture/appliance dental drill bit, single-use

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 devices1,279in commercial distribution
Companies22labelers on GUDID
Single‑use98%of device records
Sterile83%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Nobel Biocare Ab27722%
Zimvie Us Corp Llc24319%
Southern Implants (Pty) Ltd15112%
Institut Straumann Ag1058%
Dentsply Implants Manufacturing Gmbh897%
Altatec Gmbh806%
Sewon Medix Inc.645%
Biohorizons Implant Systems, Inc605%

Top labelers

CompanyDevicesShare
Nobel Biocare Ab27722%
Zimvie Us Corp Llc24319%
Southern Implants (Pty) Ltd15112%
Institut Straumann Ag1058%
Dentsply Implants Manufacturing Gmbh897%
Altatec Gmbh806%
Sewon Medix Inc.645%
Biohorizons Implant Systems, Inc605%
Neoss Ab524%
Thommen Medical Ag423%
Iq Dental Supply Llc282%
Osstem Implant Co., Ltd.222%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DS ImplantsDS OmniTaperXiVE®Astra Tech Implant System®NobelReplace®NobelZygoma™ TiUltra™Nobel Biocare N1™NobelParallel™Nobel Biocare®Brånemark System®NobelZygoma™SR DrillMini Screw Removal DrillN/ANANeoss Implant System

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

FDA product codes

CodeNameDevices
NDPAccessories, implant, dental, endosseous503
NDPAccessories, Implant, Dental, Endosseous364
DZADrill, Dental, Intraoral74
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS69
DZEImplant, Endosseous, Root-Form64
DZADRILL, DENTAL, INTRAORAL52

GMDN & GCC registration

  • GMDN code 45697 · non‑implantable
  • Single‑use 98% · sterile 83% · Rx‑only 84% · 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) · 424Length (Millimeter) · 294Lumen/Inner Diameter (Millimeter) · 13

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

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

1,279 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, single-use", from 22 companies. The largest labeler is Nobel Biocare Ab with 22% of records.

Which FDA product codes apply?

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