Consulting Wallah › Device Explorer › Dental › Dental drilling system attachment
Device Explorer · FDA GUDID · GMDN 31823

Dental drilling system attachment

A device, e.g., a straight, contra-angle or right-angle attachment, that is connected to a drill handpiece to achieve a specific function such as accessing intraoral areas that are difficult to reach when cleaning teeth, or preparing dental cavities for restor

US‑registered devices74in commercial distribution
Companies5labelers on GUDID
Single‑use31%of device records
Sterile31%labelled sterile
Prescription45%Rx‑only share
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Share of device records

Mk-Dent Gmbh4054%
Osseolink Usa Llc2331%
Intra-Lock International, Inc.912%
American Dental Implant Corporation11%
Biohorizons Implant Systems, Inc11%

Top labelers

CompanyDevicesShare
Mk-Dent Gmbh4054%
Osseolink Usa Llc2331%
Intra-Lock International, Inc.912%
American Dental Implant Corporation11%
Biohorizons Implant Systems, Inc11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MK-dent Germany®American Dental ImplantBioHorizonsDelfin2DELFIN2Delfinosseolink Implant

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

FDA product codes

CodeNameDevices
EFBHandpiece, Air-Powered, Dental40
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM23
EFAHandpiece, Belt And/Or Gear Driven, Dental6
NDPAccessories, Implant, Dental, Endosseous2
EGSHandpiece, Contra- And Right-Angle Attachment, Dental2
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS1

GMDN & GCC registration

  • GMDN code 31823 · non‑implantable
  • Single‑use 31% · sterile 31% · Rx‑only 45% · OTC 55%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 23Height (Millimeter) · 14

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

How many dental drilling system attachment products are registered in the US?

74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental drilling system attachment", from 5 companies. The largest labeler is Mk-Dent Gmbh with 54% of records.

Which FDA product codes apply?

EFB (Handpiece, Air-Powered, Dental), DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM), EFA (Handpiece, Belt And/Or Gear Driven, Dental), 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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