FDA.reportPublic FDA data

Colgate Prorelief Sensitivity Relief Serum

Primary DI
00035000466426
Brand
Colgate Prorelief Sensitivity Relief Serum
Company
COLGATE ORAL PHARMACEUTICALS, INC.
Model
US05562A
Device description
Colgate ProRelief is designed for the management of sensitive teeth. The product is applied to any sensitive teeth with the Pro-Relief sonic applicator which the head is filled with serum and massaged on to each sensitive tooth.
Published
2018-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00035000466426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00035000466426000350004664260350004664260035000466426

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
7328787396Ludjane_Carvalho@colpal.com

Regulatory Flags#

DUNS number
968801118
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
00035000983749Colgate Profesional Sensitivity Relief Serum TubeUS06793A2021-01-18
10035000970869Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850006606757Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606788Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606795Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606825Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606832Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00197998150340Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150371Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150401Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150432Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150463Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150494Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150517Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219092Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219108Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219115Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219139Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219146Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219214Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998486050Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
E22122751VOCO Profluorid Varnish + BioMinVOCO GmbHLBH2026-07-26
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10