FDA.reportPublic FDA data

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

Primary DI
00827854027577
Brand
Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)
Company
TOM'S OF MAINE, INC.
Model
61054142
Device description
Refreshing Mint
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103461000COLGATE DESENSITIZING DENTAL CREAMColgate-Palmolive Co.2011-09-13LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827854027577PackageGS11In Commercial Distribution
10827854027574PackageGS124In Commercial Distribution
20827854027571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827854027577008278540275778278540275770827854027577
1082785402757410827854027574
2082785402757120827854027571

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity varnishA liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-367-8667xx@xx.xx

Regulatory Flags#

DUNS number
829517189
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste 610160242023-06-02
20077326835627Tom's of Maine Rapid Relief Sensitive Toothpaste6835622016-09-15
20827854027120Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)610537292025-12-15
20827854027571Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)610541422025-12-15
00827854027126Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)610537292025-12-15
10035000992977Toms Sensitive + Whitening Fluoride-Free Toothpaste 610160242023-06-02
00077326835623Tom's of Maine Rapid Relief Sensitive Toothpaste6835622016-09-15
00077326444597Tom's Rapid Relief Sensitive ToothpasteUS03535A2016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20827854027120Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
20827854027571Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
506058610873033M™ Clinpro™3M COMPANYLBH2025-10-15
10818207025064ReminGelVista DentalLBH2025-10-09
07615208299373Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10
07615208292893Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-03-20
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
07615208474459Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-04-05
07615208474091Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-03-25
106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839703M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839873M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839943M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840073M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840143M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840213M™ Clinpro™3M COMPANYLBH2023-12-14
10810111542873FluoroCalBISCO INC.LBH2023-12-11
10810111542897FluoroCalBISCO INC.LBH2023-12-11
10371347011590Advance Dental ProductsThe Atlanta Dental Supply CompanyLBH2023-11-29
10732224005550Sparkle V Sodium Fluoride Varnish, CherryCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005567Sparkle V Sodium Fluoride Varnish, CaramelCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005574Sparkle V Sodium Fluoride Varnish, MelonCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224000302Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
10732224000319Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste TOM'S OF MAINE, INC.LBH2023-06-02
20810063753928Safco CleanCare Essential Prophy PasteSAFCO DENTAL SUPPLY CO.LBH2022-12-02