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Evanesce™ Nano-Enhanced Universal Restorative Single Dose Sample Pack 973201

by Den-Mat Holdings, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00359883003463 UDI-DI Date12 Mar 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Evanesce™ Nano-Enhanced Universal Restorative Single Dose Sample Pack
Generic Name
Dental composite resin
Model / Ref / Catalog
973201
Primary DI / UDI-DI
00359883003463
510(k) Number
FDA Product Code
EBF
GMDN Term
Dental composite resin
Device Class
Class II
Regulation Number
872.3690
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.25 Gram

Related devices

Category: Dental composite resin

Cleared under the same submission (K984484)

Show all (12)

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Properties

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

Other properties (9)

  • Sterile: 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