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Device Explorer · FDA GUDID · GMDN 61646

Dental prosthesis/implant abutment screw analog, reusable

A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used in

US‑registered devices543in commercial distribution
Companies26labelers on GUDID
Single‑use68%of device records
Sterile1%labelled sterile
Prescription46%Rx‑only share
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Share of device records

Prismatik Dentalcraft, Inc12122%
Implant Protesis Dental 2004 Sl8816%
Medentika Gmbh6211%
Osstem Implant Co., Ltd.418%
I3 Implant Llc397%
Titan Implant Inc377%
Southern Implants (Pty) Ltd275%
Pointimplant Co., Ltd.224%

Top labelers

CompanyDevicesShare
Prismatik Dentalcraft, Inc12122%
Implant Protesis Dental 2004 Sl8816%
Medentika Gmbh6211%
Osstem Implant Co., Ltd.418%
I3 Implant Llc397%
Titan Implant Inc377%
Southern Implants (Pty) Ltd275%
Pointimplant Co., Ltd.224%
Adin Dental Implant Systems Ltd153%
Henry Schein, Inc.153%
Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi153%
Altatec Gmbh132%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Impression copingsPaltopWP CloseFit™ Close Tray Transfer Screw ShortWP CloseFit™ Close Tray Transfer Screw LongRP CloseFit™ Close Tray Transfer Screw LongRP CloseFit™ Close Tray Transfer Screw ShortWP CloseFit™ Open Tray Transfer ScrewWP CloseFit™ Open Tray Transfer Screw ShortTMA Screw For Open Tray Impression CopyingRS Open Tray Screw For Connection AbutmentRP CloseFit™ Open Tray Transfer ScrewRP CloseFit™ Open Tray Transfer Screw ShortRP Open Tray Transfer ScrewRP Closed Tray Transfer ScrewNP CloseFit™ Open Tray Transfer ScrewNP Open Tray Transfer Screw

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, Endosseous264
NDPAccessories, implant, dental, endosseous261
NHAAbutment, Implant, Dental, Endosseous43
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS35
DZEImplant, Endosseous, Root-Form13
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM2

GMDN & GCC registration

  • GMDN code 61646 · non‑implantable
  • Single‑use 68% · sterile 1% · Rx‑only 46% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Millimeter) · 9Outer Diameter (Millimeter) · 4Length (Millimeter) · 3

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

How many dental prosthesis/implant abutment screw analog, reusable products are registered in the US?

543 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis/implant abutment screw analog, reusable", from 26 companies. The largest labeler is Prismatik Dentalcraft, Inc with 22% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), NHA (Abutment, 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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