Consulting Wallah › Device Explorer › Dental › Dental implant abutment analog, intraoral-scanning
Device Explorer · FDA GUDID · GMDN 61641

Dental implant abutment analog, intraoral-scanning, single-use

An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in

US‑registered devices2,949in commercial distribution
Companies52labelers on GUDID
Single‑use66%of device records
Sterile1%labelled sterile
Prescription65%Rx‑only share
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Share of device records

Truabutment Korea Co.,Ltd43015%
Implant Protesis Dental 2004 Sl29810%
Zirkonzahn Srl2599%
Terrats Medical Sl.2378%
Prismatik Dentalcraft, Inc2037%
Medentika Gmbh1485%
Dio Corporation1164%
Rp - Conexoes Restauradoras Ltda1023%

Top labelers

CompanyDevicesShare
Truabutment Korea Co.,Ltd43015%
Implant Protesis Dental 2004 Sl29810%
Zirkonzahn Srl2599%
Terrats Medical Sl.2378%
Prismatik Dentalcraft, Inc2037%
Medentika Gmbh1485%
Dio Corporation1164%
Rp - Conexoes Restauradoras Ltda1023%
Preat Corporation843%
Pointimplant Co., Ltd.813%
Coremedtech Aps712%
Nt-Trading Gmbh & Co. Kg682%

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

Brand names on the register (sample)

Scanning dental implant abutmentPaltopTITE-FIT WIDE/TAPERED TITE-FIT WIDETITE-FIT/TAPERED TITE-FITVISIONLOGIC /IMPLEX /EXPERTSELF THREADSELF THREAD/LOGIC PLUS/SPARKSingle TMA Scan Body 9 mmSingle TMA Scan Body 6 mmUniFit Scan Body 10mmUniFit Scan Body 7mmTMA Scan Body 9mmTMA Scan Body 6mmUNP CloseFit™ Scan Body 10mmUNP CloseFit™ Scan Body 7mm

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, Endosseous2,092
NDPAccessories, implant, dental, endosseous662
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS216
NHAAbutment, Implant, Dental, Endosseous70
DZEImplant, Endosseous, Root-Form5
DNPThin Layer Chromatography, Ethosuximide1

GMDN & GCC registration

  • GMDN code 61641 · non‑implantable
  • Single‑use 66% · sterile 1% · Rx‑only 65% · 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) · 38Height (Millimeter) · 12

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

How many dental implant abutment analog, intraoral-scanning, single-use products are registered in the US?

2,949 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant abutment analog, intraoral-scanning, single-use", from 52 companies. The largest labeler is Truabutment Korea Co.,Ltd with 15% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), NDP (ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS), NHA (Abutment, 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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