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FluroShield® Visible Light Cure Pit & Fissure Sealant 643350

by Dentsply International

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD0026433501 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
FluroShield® Visible Light Cure Pit & Fissure Sealant
Generic Name
Silicone dental impression material
Model / Ref / Catalog
643350
Primary DI / UDI-DI
D0026433501
510(k) Number
FDA Product Code
EBC
GMDN Term
Silicone dental impression material
Device Class
Class II
Regulation Number
872.3765
GUDID distribution status
In Commercial Distribution
Size
Weight — 5 Gram
Total Volume — 10 Milliliter

Related devices

Category: Silicone dental impression material

Cleared under the same submission (K896341)

Other devices from Dentsply International

See all devices from Dentsply International →

Properties

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

Other properties (10)

  • 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
  • Manufacturing Date: No