FDA.reportPublic FDA data

Colgate Prorelief Sensitivity Relief Serum

Primary DI
00035000466396
Brand
Colgate Prorelief Sensitivity Relief Serum
Company
COLGATE-PALMOLIVE COMPANY
Model
US05563A
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
00035000466396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00035000466396000350004663960350004663960035000466396

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
732-878-7367Yonca_Aksemsettinoglu@colpal.com

Regulatory Flags#

DUNS number
001344381
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10090205025264EltaMD SilverGel 16 oz025262022-12-13
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