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OptiBond Universal 36519

by Kerr Corporation

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 Number00841396121173 UDI-DI Date31 Mar 2017ListedStatusListed 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  • Withdrawn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
OptiBond Universal
Generic Name
Dentine bonding agent/set
Model / Reference
36519
Primary DI / UDI-DI
00841396121173
FDA Product Code
KLE
GMDN Term
Dentine bonding agent/set
Device Class
Class II
Regulation Number
872.3200
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Related devices

Category: Dentine bonding agent/set

Other devices from Kerr Corporation

See all devices from Kerr Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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
  • Manufacturing Date: No