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Diamodent AK1001

by Diamodent

Diamodent AK1001 is a Class II device made by Diamodent, listed in FDA GUDID since 4 Jan 2019 (UDI-DI D907AK10010), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD907AK10010 UDI-DI Date4 Jan 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Diamodent
Generic name
Dental implant suprastructure, permanent, preformed
Description
Compatible with: 4.1mm Platform Internal BIOMET 3i Certain implants Zirconia Abutment Base, Titanium, Blue Non-Hexed, 0.35mm Collar, 4.6mm Profile, 3.0mm Height
Catalogue number
AK1001
Primary DI / UDI-DI
D907AK10010
FDA product code
DZE
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution
Sterilisation method
Dry Heat Sterilization

Related devices

Category: Dental implant suprastructure, permanent, preformed

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Properties

  • Sterilise before use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)