Consulting Wallah › Device Explorer › Dental › Basket endosteal dental implant, one-piece
Device Explorer · FDA GUDID · GMDN 55843

Basket endosteal dental implant, one-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e

US‑registered devices54in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription19%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Chengdu Besmile Medical Technology Co., Ltd.4481%
Bicon, Llc1019%

Top labelers

CompanyDevicesShare
Chengdu Besmile Medical Technology Co., Ltd.4481%
Bicon, Llc1019%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIORES Dental Implant SystemImplantBrevis

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-Form55

GMDN & GCC registration

  • GMDN code 55843 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 19% · 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

No structured size data on the register.

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

How many basket endosteal dental implant, one-piece products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Basket endosteal dental implant, one-piece", from 2 companies. The largest labeler is Chengdu Besmile Medical Technology Co., Ltd. with 81% of records.

Which FDA product codes apply?

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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