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Dentin Desensitizing with Fluoride DDS

by American Dental Products Inc

Listed FDA GUDID listing, not in commercial distribution

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 Number00865849000204 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Dentin Desensitizing with Fluoride
Generic Name
Dental coating, tooth-desensitizing
Model / Reference
DDS
Primary DI / UDI-DI
00865849000204
510(k) Number
FDA Product Code
KLE
GMDN Term
Dental coating, tooth-desensitizing
Device Class
Class II
Regulation Number
872.3200
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K973185)

Other devices from American Dental Products Inc

See all devices from American Dental Products Inc →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No