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Dio Biotite-H Implant Systems Sah 4035T

by DIO Corporation

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806195922163 UDI-DI Date19 Jan 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Dio Biotite-H Implant Systems
Generic Name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
SAH 4035T
Primary DI / UDI-DI
08806195922163
FDA Product Code
NHA
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class II
Regulation Number
872.3630
GUDID distribution status
Not in Commercial Distribution

Other devices from DIO Corporation

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Properties

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

Other properties (6)

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