Duns Number:877942011
Device Description: A non-sterile substance intended to be applied to exposed dentine (resulting from enamel e 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.
Catalog Number
-
Brand Name
DDS Dentin Desensitizer System with Fluoride
Version/Model Number
G6
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K973185
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
a916e620-e54f-434b-948e-9dc560e00d22
Public Version Date
January 11, 2021
Public Version Number
5
DI Record Publish Date
January 13, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |