Consulting Wallah › Device Explorer › Dental › Dental implant internal thread shaping tool
Device Explorer · FDA GUDID · GMDN 64528

Dental implant internal thread shaping tool

A cylindrical rod with a spiralled cutting distal end, similar to a drill bit or a screw, intended to be used to shape and rectify the internal thread of a dental implant that has been implanted into bone. It is made of metal and is designed to be attached to

US‑registered devices58in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile3%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Institut Straumann Ag3459%
Southern Implants (Pty) Ltd814%
Medentika Gmbh814%
Jjgc Indústria E Comércio De Materiais Dentários S/A.610%
Sweden & Martina Spa23%

Top labelers

CompanyDevicesShare
Institut Straumann Ag3459%
Southern Implants (Pty) Ltd814%
Medentika Gmbh814%
Jjgc Indústria E Comércio De Materiais Dentários S/A.610%
Sweden & Martina Spa23%

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

Brand names on the register (sample)

NAMEDENTiKATHREAD FORMER M.1.8THREAD FORMER M.2Neodent

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, endosseous48
NDPAccessories, Implant, Dental, Endosseous10

GMDN & GCC registration

  • GMDN code 64528 · non‑implantable
  • Single‑use 100% · sterile 3% · Rx‑only 93% · 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) · 9Angle (degree) · 2

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

How many dental implant internal thread shaping tool products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant internal thread shaping tool", from 5 companies. The largest labeler is Institut Straumann Ag with 59% of records.

Which FDA product codes apply?

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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