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Dentin Desensitizer with Fluoride 10 ml

by American Dental Products Inc 2 variants

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 Number00865849000242 UDI-DI Date26 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  • Withdrawn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 Desensitizer with Fluoride
Generic Name
Dental coating, tooth-desensitizing
Model / Ref / Catalog
10 ml, 9515140
Primary DI / UDI-DI
00865849000242
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
Size
Total Volume — 10 Milliliter

Related devices

Cleared under the same submission (K973185)

Other devices from American Dental Products Inc

See all devices from American Dental Products Inc →

Properties

  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

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