Dentin Desensitizing with Fluoride

GUDID 00865849000204

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.

AMERICAN DENTAL PRODUCTS INC

Dental coating, tooth-desensitizing

• Primary Device ID: 00865849000204
• NIH Device Record Key: c40b654f-3de2-4509-949c-75c2f5b79332
• Commercial Distribution Discontinuation: 2021-01-09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentin Desensitizing with Fluoride
• Version Model Number: DDS
• Company DUNS: 877942011
• Company Name: AMERICAN DENTAL PRODUCTS INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865849000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973185

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-09-22

Devices Manufactured by AMERICAN DENTAL PRODUCTS INC

• 00865849000204 - Dentin Desensitizing with Fluoride: 2019-11-11A 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.
• 00865849000204 - Dentin Desensitizing with Fluoride: 2019-11-11 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio
• 00865849000242 - Dentin Desensitizer with Fluoride: 2019-05-15 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio
• 00865849000211 - DDS Dentin Desensitizer System with Fluoride: 2019-02-07 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio
• 00865849000228 - Dentin Desensitizer with Fluoride: 2019-02-07 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio