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Alpha Dent Implants Implant Active Bio Plus Ø5.0 L8

by Alpha Dent Implants GmbH GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04060474007888 UDI-DIDate30 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Alpha Dent Implants
Generic Name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
Implant Active Bio Plus Ø5.0 L8, IAB +5.0x8
Primary DI / UDI-DI
04060474007888
510(k) Number
FDA Product Code
DZE
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K240435)

Show all (12)

Other devices from Alpha Dent Implants GmbH

See all devices from Alpha Dent Implants GmbH →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No