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Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz) 61054142

by Tom's of Maine, Inc.

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 Number20827854027571 UDI-DI Date15 Dec 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  • Withdrawn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
Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)
Generic Name
Dental cavity varnish
Model / Reference
61054142
Primary DI / UDI-DI
20827854027571
510(k) Number
FDA Product Code
LBH
GMDN Term
Dental cavity varnish
Device Class
Class II
Regulation Number
872.3260
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K103461)

Other devices from Tom's of Maine, Inc.

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No