Consulting Wallah › Device Explorer › Dental › Dental implant suprastructure, temporary, preforme
Device Explorer · FDA GUDID · GMDN 46122

Dental implant suprastructure, temporary, preformed, reusable

A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing

US‑registered devices2,786in commercial distribution
Companies31labelers on GUDID
Single‑use10%of device records
Sterile1%labelled sterile
Prescription84%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Zirkonzahn Srl1,00736%
Nobel Biocare Ab48818%
Dentsply Implants Manufacturing Gmbh2077%
Medentika Gmbh2027%
Elos Medtech Pinol A/S1746%
Biotechnology Institute Sl1395%
Institut Straumann Ag994%
Biotech Dental793%

Top labelers

CompanyDevicesShare
Zirkonzahn Srl1,00736%
Nobel Biocare Ab48818%
Dentsply Implants Manufacturing Gmbh2077%
Medentika Gmbh2027%
Elos Medtech Pinol A/S1746%
Biotechnology Institute Sl1395%
Institut Straumann Ag994%
Biotech Dental793%
Etablissements Anthogyr522%
Diamodent Inc492%
Quantum Bioengineering Ltd.452%
Thommen Medical Ag321%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ATLANTIS®DS OmniTaperDS ImplantsXiVE®ANKYLOS®Astra Tech Implant System®NANobelProcera®Omnigrip™Nobel Biocare®Nobel Biocare N1™On1™Multi-unit AbutmentBrånemark System®Trefoil™NobelActive®

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, endosseous2,405
NDPAccessories, Implant, Dental, Endosseous455
DZEImplant, Endosseous, Root-Form47
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS46
NHAAbutment, Implant, Dental, Endosseous40
DZLScrew, Fixation, Intraosseous8

GMDN & GCC registration

  • GMDN code 46122 · implantable
  • Single‑use 10% · sterile 1% · Rx‑only 84% · 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) · 378Height (Millimeter) · 279Length (Millimeter) · 132Angle (degree) · 54

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

How many dental implant suprastructure, temporary, preformed, reusable products are registered in the US?

2,786 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant suprastructure, temporary, preformed, reusable", from 31 companies. The largest labeler is Zirkonzahn Srl with 36% of records.

Which FDA product codes apply?

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