DEVICE: Colgate PreviDent Varnish Raspberry (00038341330395)

Device Identifier (DI) Information

Colgate PreviDent Varnish Raspberry
733098
In Commercial Distribution

COLGATE ORAL PHARMACEUTICALS, INC.
00038341330395
GS1

1
968801118 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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Yes
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GMDN

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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 non-sterile 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.
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FDA Product Code

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Product Code Product Code Name
LBH Varnish, Cavity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a cool dry place
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7a2b9b28-5657-4168-8870-13aed04b5d93
July 30, 2018
4
September 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10038341330392 12 00038341330395 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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732-878-7367
Yonca_Aksemsettinoglu@colpal.com
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