Consulting Wallah › Device Explorer › Orthopaedic implants › Dental implantation drilling template stabilizatio
Device Explorer · FDA GUDID · GMDN 64372

Dental implantation drilling template stabilization bolt

A threaded bolt with a proximal flange intended to be used with a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation), to temporarily fix the template to a dental implant, immediately

US‑registered devices91in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Arum Dentistry Co., Ltd.3640%
Cowellmedi Co.,Ltd2224%
Osstem Implant Co., Ltd.1213%
Jjgc Indústria E Comércio De Materiais Dentários S/A.1112%
Noris Medical Ltd89%
Pointimplant Co., Ltd.22%

Top labelers

CompanyDevicesShare
Arum Dentistry Co., Ltd.3640%
Cowellmedi Co.,Ltd2224%
Osstem Implant Co., Ltd.1213%
Jjgc Indústria E Comércio De Materiais Dentários S/A.1112%
Noris Medical Ltd89%
Pointimplant Co., Ltd.22%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Fixation screwFixation pinOneGuide TS Implant AnchorOneGuide KS Implant AnchorDental InstrumentImplant Anchor ScrewImplant AnchorOneGuide Implant AnchorOneGuide Fixture AnchorVertical AnchorNeodent

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, Endosseous75
NDPAccessories, implant, dental, endosseous11
DZADrill, Dental, Intraoral6

GMDN & GCC registration

  • GMDN code 64372 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 49% · 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

Length (Millimeter) · 3Outer Diameter (Millimeter) · 1

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

How many dental implantation drilling template stabilization bolt products are registered in the US?

91 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implantation drilling template stabilization bolt", from 6 companies. The largest labeler is Arum Dentistry Co., Ltd. with 40% of records.

Which FDA product codes apply?

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

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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