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Accessory X-80251P

by Bisco Inc.

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 Number20810111542689 UDI-DI Date21 Nov 2022ListedStatusListed 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  • Withdrawn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
Accessory
Generic name
Dental material application tool, single-use
Model / Ref / Catalog
X-80251P
Primary DI / UDI-DI
20810111542689
FDA product code
KXR
GMDN term
Dental material application tool, single-use
Device class
Class I
Regulation number
872.3140
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental material application tool, single-use

Other devices from Bisco Inc.

See all devices from Bisco Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No