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Fixture POF6011QNP

by POINTIMPLANT Co., Ltd.

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

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 Number08800011211899 UDI-DI Date13 Feb 2025ListedStatusListed 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  • Withdrawn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
Fixture
Generic name
Screw endosteal dental implant, two-piece
Model / reference
POF6011QNP
Primary DI / UDI-DI
08800011211899
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

Category: Screw endosteal dental implant, two-piece

Other devices from POINTIMPLANT Co., Ltd.

See all devices from POINTIMPLANT Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Sterilise before use: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No