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12 Gm Etch Gel with 25 Tips BSET15

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 Number10190886000519 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  • Withdrawn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
12 Gm Etch Gel with 25 Tips
Generic Name
Dental tooth-etching solution
Model / Reference
BSET15
Primary DI / UDI-DI
10190886000519
510(k) Number
FDA Product Code
DYH
GMDN Term
Dental tooth-etching solution
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.

See all devices from G&H Wire Company, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No