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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 Number00865849000228 UDI-DI Date29 Jan 2018ListedStatusListed 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  • Withdrawn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
00865849000228
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
MRI Safety
MR Safe
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

  • 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