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Regisil® Rigid digit® Super Fast Set Targeted Delivery System 619021

by Dentsply International

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD0026190211 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Regisil® Rigid digit® Super Fast Set Targeted Delivery System
Generic Name
Silicone dental impression material
Model / Ref / Catalog
619021
Primary DI / UDI-DI
D0026190211
FDA Product Code
ELW
GMDN Term
Silicone dental impression material
Device Class
Class II
Regulation Number
872.3660
GUDID distribution status
Not in Commercial Distribution

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Properties

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

Other properties (10)

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