Consulting Wallah › Device Explorer › Dental › Dental implant suprastructure, permanent, preforme
Device Explorer · FDA GUDID · GMDN 44879

Dental implant suprastructure, permanent, preformed

A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, ba

US‑registered devices66,891in commercial distribution
Companies124labelers on GUDID
Single‑use99%of device records
Sterile13%labelled sterile
Prescription87%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Megagen Implant Co. Ltd4,9257%
Osstem Implant Co., Ltd.4,7217%
Rhein 83 Srl3,4645%
Terrats Medical Sl.3,1565%
Dentis Co. ,Ltd2,7854%
Cybermed Inc.2,6094%
Medentika Gmbh2,5814%
Zest Anchors, Llc2,5064%

Top labelers

CompanyDevicesShare
Megagen Implant Co. Ltd4,9257%
Osstem Implant Co., Ltd.4,7217%
Rhein 83 Srl3,4645%
Terrats Medical Sl.3,1565%
Dentis Co. ,Ltd2,7854%
Cybermed Inc.2,6094%
Medentika Gmbh2,5814%
Zest Anchors, Llc2,5064%
Preat Corporation2,2233%
Nobel Biocare Ab1,7863%
Truabutment Korea Co.,Ltd1,5592%
Jjgc Indústria E Comércio De Materiais Dentários S/A.1,5422%

Company = labeler of record on GUDID. 124 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IPS e.max CAD AbutmentSolutionATLANTIS®DS ImplantsAtlantisFRIADENT®XiVE®ANKYLOS®N/AASTRA TECH Implant System® EVAstra Tech Implant System® EVATLANTIS™Astra Tech Implant System®Nobel Biocare N1™Universal BaseNobelProcera®Nobel Biocare®

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, Endosseous44,515
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS13,670
NHAAbutment, implant, dental, endosseous8,362
DZEImplant, Endosseous, Root-Form2,833
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM1,577
PNPDental Abutment Design Software For Dental Laboratory745

GMDN & GCC registration

  • GMDN code 44879 · implantable
  • Single‑use 99% · sterile 13% · Rx‑only 87% · 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

Length (Millimeter) · 4,965Outer Diameter (Millimeter) · 4,335Height (Millimeter) · 3,812Angle (degree) · 1,553Width (Millimeter) · 97Weight (Gram) · 7

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

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

66,891 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant suprastructure, permanent, preformed", from 124 companies. The largest labeler is Megagen Implant Co. Ltd with 7% of records.

Which FDA product codes apply?

NHA (Abutment, Implant, Dental, Endosseous), NHA (ABUTMENT, 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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