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Device Explorer · FDA GUDID · GMDN 61647

Dental prosthesis/implant abutment screw

A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener

US‑registered devices2,321in commercial distribution
Companies52labelers on GUDID
Single‑use98%of device records
Sterile9%labelled sterile
Prescription90%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Cowellmedi Co.,Ltd33514%
Terrats Medical Sl.23510%
Nobel Biocare Ab1466%
Preat Corporation1436%
Talladium España Sl1396%
Prismatik Dentalcraft, Inc1306%
Implant Protesis Dental 2004 Sl1286%
Elos Medtech Pinol A/S834%

Top labelers

CompanyDevicesShare
Cowellmedi Co.,Ltd33514%
Terrats Medical Sl.23510%
Nobel Biocare Ab1466%
Preat Corporation1436%
Talladium España Sl1396%
Prismatik Dentalcraft, Inc1306%
Implant Protesis Dental 2004 Sl1286%
Elos Medtech Pinol A/S834%
Southern Implants (Pty) Ltd813%
Soadco, S.L.653%
Titan Implant Inc643%
Dio Corporation643%

Company = labeler of record on GUDID. 52 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAOmnigrip™NobelZygoma™ TiUltra™NobelProcera®Trefoil™Nobel Biocare®Brånemark System®NobelZygoma™Multi-unit AbutmentNobelReplace®Nobel Biocare N1™On1™Procera®Transfer ScrewPaltopPROSTHETIC SCREWS

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

FDA product codes

CodeNameDevices
NHAAbutment, Implant, Dental, Endosseous1,390
NHAAbutment, implant, dental, endosseous504
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS479
PNPDental Abutment Design Software For Dental Laboratory128
NDPAccessories, Implant, Dental, Endosseous117
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM65

GMDN & GCC registration

  • GMDN code 61647 · implantable
  • Single‑use 98% · sterile 9% · Rx‑only 90% · 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

Height (Millimeter) · 105Length (Millimeter) · 66Outer Diameter (Millimeter) · 44Width (Millimeter) · 16Angle (degree) · 2

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

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

2,321 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", from 52 companies. The largest labeler is Cowellmedi Co.,Ltd with 14% of records.

Which FDA product codes apply?

NHA (Abutment, Implant, Dental, Endosseous), NHA (Abutment, implant, dental, endosseous), NHA (ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS), PNP (Dental Abutment Design Software For Dental Laboratory)

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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