Colgate Prorelief Sensitivity Relief Serum

Basic Information

• Brand Name: Colgate Prorelief Sensitivity Relief Serum
• Primary DI: 00035000466426
• Version / Model: US05562A
• Company Name: COLGATE ORAL PHARMACEUTICALS, INC.
• Labeler DUNS: 968801118
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 2
• Public Version Date: 2022-12-15
• Public Version Status: Update
• Public Device Record Key: 877de8e7-a804-4d56-98a9-d622f535cd8b
• Distribution End Date: 2021-03-31

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	Varnish, Cavity	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35698	Dental cavity varnish	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00035000466426	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]