FDA.reportPublic FDA data

Colgate Profesional Sensitivity Relief Serum Tube

Primary DI
00035000983749
Brand
Colgate Profesional Sensitivity Relief Serum Tube
Company
COLGATE ORAL PHARMACEUTICALS, INC.
Model
US06793A
Device description
Colgate Profesional Sensitivity Relief Serum is designed to provide rapid sensitivity relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. The product is directly applied to any sensitive teeth with the fingertip and gently massaged for 1 minute. Pea-sized amount should be used on each direct application and repeated as needed on daily basis
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
00035000983749PackageGS110In Commercial Distribution
00035000977786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00035000983749000350009837490350009837490035000983749
00035000977786000350009777860350009777860035000977786

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(732) 878-6160garo_mimaryan@colpal.com
7328787396Ludjane_Carvalho@colpal.com

Regulatory Flags#

DUNS number
968801118
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
00035000990754Colgate Optic White Professional Take-Home Whitening Kit610125612023-06-08
00827854000587Colgate Optic White Professional In Office Whitening Kit610201172023-06-08
00301260033228Colgate Optic White Professional Take-Home KitLWT32026-01-26
10301260033218Colgate Optic White Professional Take-Home KitLWT32026-01-26
00035000465214Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14
00035000977786Colgate Profesional Sensitivity Relief Serum TubeUS06793A2021-01-18
00035000465467Colgate Anywhere Anytime Sensitivity Relief SerumUS05495A2018-05-31
00035000466426Colgate Prorelief Sensitivity Relief SerumUS05562A2018-05-31
00301260033211Colgate Optic White Professional In Office Whitening Kit610482812025-11-06
00035000985835Colgate Total FlossUS07353A2023-08-15
00038341330388Colgate PreviDent Varnish Mint7330962016-09-15
00038341330937Colgate PreviDent Varnish Grape 7330932016-09-15
00038341457955Colgate PreviDent Varnish Caramel SundaeUS05089A2018-05-31
00038341451168Colgate PreviDent Varnish Raspberry - unit doseUS04261A2019-04-08
10035000990751Colgate Optic White Professional Take-Home Whitening Kit610125612023-06-08
00038341330395Colgate PreviDent Varnish Raspberry7330982016-09-15
10035000970869Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14

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