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Device Explorer · FDA GUDID · GMDN 44880

Dental implant suprastructure, temporary, preformed, single-use

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 devices17,017in commercial distribution
Companies102labelers on GUDID
Single‑use97%of device records
Sterile37%labelled sterile
Prescription83%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Megagen Implant Co. Ltd1,0516%
Dentis Co. ,Ltd9526%
Hiossen, Inc.9235%
Zimvie Us Corp Llc6674%
Southern Implants (Pty) Ltd6254%
Altatec Gmbh6114%
Dentsply Implants Manufacturing Gmbh5743%
Jjgc Indústria E Comércio De Materiais Dentários S/A.5103%

Top labelers

CompanyDevicesShare
Megagen Implant Co. Ltd1,0516%
Dentis Co. ,Ltd9526%
Hiossen, Inc.9235%
Zimvie Us Corp Llc6674%
Southern Implants (Pty) Ltd6254%
Altatec Gmbh6114%
Dentsply Implants Manufacturing Gmbh5743%
Jjgc Indústria E Comércio De Materiais Dentários S/A.5103%
Osstem Implant Co., Ltd.4983%
Titan Implant Inc4763%
Arum Dentistry Co., Ltd.4703%
Institut Straumann Ag4513%

Company = labeler of record on GUDID. 102 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DS OmniTaperDS ImplantsFRIADENT®XiVE®XiVE® TGN/AANKYLOS®Astra Tech Implant System®ASTRA TECH Implant System® EVASTRA TECH Implant System®Temporary Abutment CCNobel Biocare®Nobel Biocare N1™Trefoil™On1™NobelProcera®

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, Endosseous7,227
NDPAccessories, Implant, Dental, Endosseous5,067
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1,717
NDPAccessories, implant, dental, endosseous1,534
NHAAbutment, implant, dental, endosseous1,084
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM715

GMDN & GCC registration

  • GMDN code 44880 · implantable
  • Single‑use 97% · sterile 37% · Rx‑only 83% · 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) · 2,021Height (Millimeter) · 1,523Length (Millimeter) · 581Angle (degree) · 57Width (Millimeter) · 35Length (Centimeter) · 2

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

How many dental implant suprastructure, temporary, preformed, single-use products are registered in the US?

17,017 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, single-use", from 102 companies. The largest labeler is Megagen Implant Co. Ltd with 6% of records.

Which FDA product codes apply?

NHA (Abutment, Implant, Dental, Endosseous), NDP (Accessories, Implant, Dental, Endosseous), NHA (ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS), NDP (Accessories, 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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