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Device Explorer · FDA GUDID · GMDN 61640

Dental implant abutment analog, laboratory

A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner).

US‑registered devices1,837in commercial distribution
Companies36labelers on GUDID
Single‑use22%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Terrats Medical Sl.44224%
Shining 3D Tech Co., Ltd.34219%
Talladium España Sl29916%
Osseofuse International, Inc.774%
Medentika Gmbh734%
Cowellmedi Co.,Ltd704%
Altatec Gmbh643%
Nobel Biocare Ab613%

Top labelers

CompanyDevicesShare
Terrats Medical Sl.44224%
Shining 3D Tech Co., Ltd.34219%
Talladium España Sl29916%
Osseofuse International, Inc.774%
Medentika Gmbh734%
Cowellmedi Co.,Ltd704%
Altatec Gmbh643%
Nobel Biocare Ab613%
Orangecad Med Gmbh573%
Titan Implant Inc442%
Biotech Dental432%
Diamodent Inc352%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Nobel Biocare®NAOn1™Implant AnalogMODULAR SYSTEMUNIVERSAL UNITTITE-FIT WIDE/TAPERED TITE-FIT WIDETITE-FIT/TAPERED TITE-FITSELF THREAD/LOGIC PLUS/SPARKBhi ImplantsPaltopSHINING 3D®EighteethElos Accurate® Scan BodySIC invent Dental Implant SystemsOrangeCAD Med

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, Endosseous1,051
NDPAccessories, implant, dental, endosseous717
NHAAbutment, Implant, Dental, Endosseous89
DZEImplant, Endosseous, Root-Form33
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS15
EJLBUR, DENTAL2

GMDN & GCC registration

  • GMDN code 61640 · non‑implantable
  • Single‑use 22% · sterile 0% · Rx‑only 71% · 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) · 18

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

How many dental implant abutment analog, laboratory products are registered in the US?

1,837 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant abutment analog, laboratory", from 36 companies. The largest labeler is Terrats Medical Sl. with 24% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), NHA (Abutment, Implant, Dental, Endosseous), DZE (Implant, Endosseous, Root-Form)

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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