Duns Number:315471722
Device Description: XENO III INTRO KIT is a 2 component single step self-etching dental adhesive. Both compone XENO III INTRO KIT is a 2 component single step self-etching dental adhesive. Both components (D010K3027080 and D010K3027090) need to be mixed before use. With its supporting accessories (Applicator Tips and Clixdish) it can be classified as a convenience kit.
Catalog Number
664100
Brand Name
XENO III
Version/Model Number
664100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 2018
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KLE
Product Code Name
AGENT, TOOTH BONDING, RESIN
Public Device Record Key
1c9447e0-4b0a-4e2e-981c-c96e6424f4f3
Public Version Date
September 23, 2022
Public Version Number
4
DI Record Publish Date
September 20, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |