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Device Explorer · FDA GUDID · GMDN 57789

Surgical drill guide, single-use

A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end t

US‑registered devices697in commercial distribution
Companies45labelers on GUDID
Single‑use93%of device records
Sterile16%labelled sterile
Prescription57%Rx‑only share
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Share of device records

Medentika Gmbh13419%
Steco-System-Technik Gmbh & Co Kg11316%
Fusion Orthopedics, Llc578%
Biodenta Swiss Ag568%
Dentsply Implants Manufacturing Gmbh467%
Biomet Orthopedics, Llc365%
Jjgc Indústria E Comércio De Materiais Dentários S/A.345%
Institut Straumann Ag345%

Top labelers

CompanyDevicesShare
Medentika Gmbh13419%
Steco-System-Technik Gmbh & Co Kg11316%
Fusion Orthopedics, Llc578%
Biodenta Swiss Ag568%
Dentsply Implants Manufacturing Gmbh467%
Biomet Orthopedics, Llc365%
Jjgc Indústria E Comércio De Materiais Dentários S/A.345%
Institut Straumann Ag345%
Altatec Gmbh325%
Osstem Implant Co., Ltd.243%
Nobel Biocare Ab162%
Biopro, Inc.132%

Company = labeler of record on GUDID. 45 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DS PrimeTaperDS OmniTaperSIMPLANT®ANKYLOS®Astra Tech Implant System®Nobel Biocare®NAPragmaToolGuide ScrewMEDENTiKANeoss Implant SystemRECAP HIP INSTRUMENTATIONPROGRESSIVE-LINE Guiding sleeveGuiding sleeveCT tubeDrill Guide Kit (0.075'')

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, endosseous294
NDPAccessories, Implant, Dental, Endosseous212
FZXGuide, Surgical, Instrument39
HWCScrew, Fixation, Bone37
FZXGuide, surgical, instrument24
LXHOrthopedic Manual Surgical Instrument22

GMDN & GCC registration

  • GMDN code 57789 · non‑implantable
  • Single‑use 93% · sterile 16% · Rx‑only 57% · OTC 16%
  • 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) · 76Length (Millimeter) · 23Lumen/Inner Diameter (Millimeter) · 15Width (Millimeter) · 4

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

How many surgical drill guide, single-use products are registered in the US?

697 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical drill guide, single-use", from 45 companies. The largest labeler is Medentika Gmbh with 19% of records.

Which FDA product codes apply?

NDP (Accessories, implant, dental, endosseous), NDP (Accessories, Implant, Dental, Endosseous), FZX (Guide, Surgical, Instrument), HWC (Screw, Fixation, Bone)

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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