Consulting Wallah › Device Explorer › Dental › Dental implant suprastructure kit
Device Explorer · FDA GUDID · GMDN 44881

Dental implant suprastructure kit

A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direc

US‑registered devices1,922in commercial distribution
Companies21labelers on GUDID
Single‑use88%of device records
Sterile0%labelled sterile
Prescription55%Rx‑only share
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Share of device records

Soadco, S.L.70837%
Shinhung Mst Co., Ltd.26414%
A.B. Dental Devices Ltd21711%
Terrats Medical Sl.1649%
Adin Dental Implant Systems Ltd1307%
Thommen Medical Ag1005%
Paltop Advanced Dental Solutions Ltd774%
Novodent Sa764%

Top labelers

CompanyDevicesShare
Soadco, S.L.70837%
Shinhung Mst Co., Ltd.26414%
A.B. Dental Devices Ltd21711%
Terrats Medical Sl.1649%
Adin Dental Implant Systems Ltd1307%
Thommen Medical Ag1005%
Paltop Advanced Dental Solutions Ltd774%
Novodent Sa764%
Blue Sky Bio Llc482%
Snucone Co.,Ltd.482%
Institut Straumann Ag281%
Dentsply Implants Manufacturing Gmbh221%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FRIADENT®XiVE®Atlas Surgical and Prosthetic Instrumentation KiAnew Surgical and Prosthetic Instrumentation KitPaltopProsthetic AccessoriesPresthetic AccessoriesToolsIRIS™, Burnout cap whiteIRIS™, Burnout anti rotation cap redIRIS™, UNP Abutment, RH 8mm GH 2mmIRIS™, UNP Abutment, RH 8mm GH 1mmIRIS™, UNP Abutment, RH 6mm GH 4mmIRIS™, UNP Abutment, RH 6mm GH 3mmIRIS™, UNP Abutment, RH 6mm GH 2mmIRIS™, UNP Abutment, RH 6mm GH 1mm

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, endosseous564
NHAAbutment, Implant, Dental, Endosseous443
NDPAccessories, implant, dental, endosseous331
EGGAttachment, Precision, All252
NDPAccessories, Implant, Dental, Endosseous197
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS113

GMDN & GCC registration

  • GMDN code 44881 · non‑implantable
  • Single‑use 88% · sterile 0% · Rx‑only 55% · 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) · 120Length (Millimeter) · 65Height (Millimeter) · 47Angle (degree) · 40

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

How many dental implant suprastructure kit products are registered in the US?

1,922 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant suprastructure kit", from 21 companies. The largest labeler is Soadco, S.L. with 37% of records.

Which FDA product codes apply?

NHA (Abutment, implant, dental, endosseous), NHA (Abutment, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), EGG (Attachment, Precision, All)

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.

How do I get quotes?

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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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