Consulting Wallah › Device Explorer › Dental › Dental implant kit
Device Explorer · FDA GUDID · GMDN 65059

Dental implant kit

A collection of prefabricated dental devices and components, which includes a dental implant, intended to be used during dental surgery and laboratory procedures to create and implant the foundation of a reconstructed tooth. In addition to the dental implant,

US‑registered devices360in commercial distribution
Companies9labelers on GUDID
Single‑use98%of device records
Sterile53%labelled sterile
Prescription58%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Jjgc Indústria E Comércio De Materiais Dentários S/A.19253%
Truabutment Korea Co.,Ltd15242%
Zest Anchors, Llc62%
Aetonmedical Llc51%
Peter Brasseler Holdings, Llc10%
Hexa Dental10%
Biohorizons Implant Systems, Inc10%
Hu Medi Tech Co., Ltd.10%

Top labelers

CompanyDevicesShare
Jjgc Indústria E Comércio De Materiais Dentários S/A.19253%
Truabutment Korea Co.,Ltd15242%
Zest Anchors, Llc62%
Aetonmedical Llc51%
Peter Brasseler Holdings, Llc10%
Hexa Dental10%
Biohorizons Implant Systems, Inc10%
Hu Medi Tech Co., Ltd.10%
Dentis Co. ,Ltd10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Brasseler USAHexaBioHorizonsLOCATORZAAGAeton MedicalKimplant KITTruBoltURIS Scan Post Kit CaseURIS Scan Post KitTruScan Post KitTruBolt KitTruScan Post Kit CaseTruScan Body KitURIS Scan Body KitAOT Plus Scan Body

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM192
NDPAccessories, Implant, Dental, Endosseous157
DZEImplant, Endosseous, Root-Form9
NHAAbutment, Implant, Dental, Endosseous6
NDPAccessories, implant, dental, endosseous5
EIGRETRACTOR, ALL TYPES1

GMDN & GCC registration

  • GMDN code 65059 · implantable
  • Single‑use 98% · sterile 53% · Rx‑only 58% · 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) · 192

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

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

360 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant kit", from 9 companies. The largest labeler is Jjgc Indústria E Comércio De Materiais Dentários S/A. with 53% of records.

Which FDA product codes apply?

DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM), 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.

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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