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Premise Flowable 33372

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 Number10841396106641 UDI-DI Date1 Aug 2016ListedStatusListed 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  • Withdrawn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
Premise Flowable
Generic Name
Light-cured dental restorative composite resin
Model / Ref / Catalog
33372
Primary DI / UDI-DI
10841396106641
FDA Product Code
EBF
GMDN Term
Light-cured dental restorative composite resin
Device Class
Class II
Regulation Number
872.3690
GUDID distribution status
In Commercial Distribution
Size
Weight — 6.8 Gram

Related devices

Category: Light-cured dental restorative composite resin

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