DEVICE: Colgate PreviDent Varnish Raspberry (00038341330395)
Device Identifier (DI) Information
Colgate PreviDent Varnish Raspberry
733098
In Commercial Distribution
COLGATE ORAL PHARMACEUTICALS, INC.
733098
In Commercial Distribution
COLGATE ORAL PHARMACEUTICALS, INC.
Colgate PreviDent Varnish 5% Sodium Fluoride has a strong desensitizing action when applied to dental surfaces treating hypersensitivity quickly and easily. This product sets rapidly on contact with saliva, resulting in patient comfort and acceptance. PreviDent will leave a thin film on the teeth after application.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Dental coating, tooth-desensitizing | A substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused. |
FDA Product Code
[?]Product Code | Product Code Name |
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LBH | Varnish, Cavity |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a cool dry place |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7a2b9b28-5657-4168-8870-13aed04b5d93
February 07, 2019
5
September 15, 2016
February 07, 2019
5
September 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10038341330392 | 12 | 00038341330395 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
732-878-7367
Yonca_Aksemsettinoglu@colpal.com
Yonca_Aksemsettinoglu@colpal.com