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Device Explorer · FDA GUDID · GMDN 61642

Dental implant analog

A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of

US‑registered devices3,333in commercial distribution
Companies69labelers on GUDID
Single‑use78%of device records
Sterile3%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Implant Protesis Dental 2004 Sl46114%
Prismatik Dentalcraft, Inc36411%
Medentika Gmbh2618%
Elos Medtech Pinol A/S2277%
Truabutment Korea Co.,Ltd1795%
Osstem Implant Co., Ltd.1615%
Blue Sky Bio Llc1394%
Talladium España Sl1174%

Top labelers

CompanyDevicesShare
Implant Protesis Dental 2004 Sl46114%
Prismatik Dentalcraft, Inc36411%
Medentika Gmbh2618%
Elos Medtech Pinol A/S2277%
Truabutment Korea Co.,Ltd1795%
Osstem Implant Co., Ltd.1615%
Blue Sky Bio Llc1394%
Talladium España Sl1174%
Preat Corporation1033%
Titan Implant Inc1023%
I3 Implant Llc903%
Henry Schein, Inc.832%

Company = labeler of record on GUDID. 69 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DS ImplantsOneTM Implant Analog 5.0D, MachinedOneTM Implant Analog 4.2D, MachinedOneTM Implant Analog 3.6D, MachinedOneTM Implant Analog 3.3D, MachinedOneTM Implant Analog 3.0D, MachinedAnalogPaltopANALOGAnalog for Multi-UnitMono Implant AnalogTitanium Implant AnalogStandard Implant AnalogToolsHI-TEC IMPLANTSTRX-OP

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, Endosseous2,098
NDPAccessories, implant, dental, endosseous746
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS235
DZEImplant, Endosseous, Root-Form95
EBLPin, Retentive And Splinting, And Accessory Instruments88
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS65

GMDN & GCC registration

  • GMDN code 61642 · non‑implantable
  • Single‑use 78% · sterile 3% · Rx‑only 64% · 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) · 154Outer Diameter (Millimeter) · 43Length (Millimeter) · 20Angle (degree) · 2Width (Millimeter) · 1

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

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

3,333 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant analog", from 69 companies. The largest labeler is Implant Protesis Dental 2004 Sl with 14% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), NDP (ACCESSORIES, 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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