Dentin Desensitizer with Fluoride 9515140

GUDID 00865849000228

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: 00865849000228
• NIH Device Record Key: 6c08f49b-bdf5-4983-a214-854b97182b97
• Commercial Distribution Discontinuation: 2021-01-09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentin Desensitizer with Fluoride
• Version Model Number: 10 ml
• Catalog Number: 9515140
• Company DUNS: 877942011
• Company Name: AMERICAN DENTAL PRODUCTS INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com
• Phone: 5166886800
• Email: robyn.livingston@darby.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865849000228 [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: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-01-29

On-Brand Devices [Dentin Desensitizer with Fluoride]

• 00865849000242: A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion
• 00865849000228: A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion