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Affinity™ Monophase w/o tips 2-Pack 025400W

by Den-Mat Holdings, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00359883002350 UDI-DI Date12 Mar 2025ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1100-2022 FDA Class II initiated 18 Mar 2022

    Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Affinity™ Monophase w/o tips 2-Pack
Generic Name
Silicone dental impression material
Model / Ref / Catalog
025400W
Primary DI / UDI-DI
00359883002350
510(k) Number
FDA Product Code
ELW
GMDN Term
Silicone dental impression material
Device Class
Class II
Regulation Number
872.3660
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 50 Milliliter

Related devices

Category: Silicone dental impression material

Cleared under the same submission (K053014)

Show all (12)

Other devices from Den-Mat Holdings, LLC

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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