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BONDPRO™ PLASTIC ENHANCER 10cc M957-01

by G&H Wire Company, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10190886000595 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
BONDPRO™ PLASTIC ENHANCER 10cc
Generic name
Dentine bonding agent/set
Model / reference
M957-01
Description
PLASTIC ENHANCER 10cc. APPLIED PRIOR TO BONDING FOR STRONGER BONDS.
Primary DI / UDI-DI
10190886000595
510(k) Number
FDA product code
DYH
GMDN term
Dentine bonding agent/set
Device class
Class II
Regulation number
872.3750
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K981036)

Other devices from G&H Wire Company, Inc.

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (11)

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