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Affinity™ Heavy Body FS 120ml 2-Pack 023406

by Den-Mat Holdings, LLC

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 Number00359883002114 UDI-DI Date12 Mar 2025ListedStatusListed 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  • Withdrawn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
Affinity™ Heavy Body FS 120ml 2-Pack
Generic Name
Silicone dental impression material
Model / Ref / Catalog
023406
Primary DI / UDI-DI
00359883002114
FDA Product Code
ELW, EID
GMDN Term
Silicone dental impression material
Device Class
Class II
Regulation Number
872.3660, 872.4565
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 120 Milliliter

Related devices

Category: Silicone dental impression material

Other devices from Den-Mat Holdings, LLC

See all devices from Den-Mat Holdings, LLC →

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