Dentin Desensitizer with Fluoride 9515140

GUDID 00865849000242

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 ID00865849000242
NIH Device Record Keycee22a38-0a5b-433e-a955-b4f0d9d09088
Commercial Distribution Discontinuation2019-05-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDentin Desensitizer with Fluoride
Version Model Number10 ml
Catalog Number9515140
Company DUNS877942011
Company NameAMERICAN DENTAL PRODUCTS INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8008467120
EmailGNChicago@gmail.com

Device Dimensions

Total Volume10 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100865849000242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-15
Device Publish Date2016-09-26

On-Brand Devices [Dentin Desensitizer with Fluoride]

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

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