Duns Number:315427286
Device Description: CONTEC lcr disposable tube / For CONTEC lcr retainer adhesive (REF 163-131-00).
Catalog Number
-
Brand Name
N.A.
Version/Model Number
163-120-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 22, 2022
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"
-
For Single-Use
Yes
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
K030644,K030644
Product Code
DYH
Product Code Name
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
Public Device Record Key
f5ffce81-4529-4eeb-8271-c56e92a0c182
Public Version Date
January 24, 2022
Public Version Number
2
DI Record Publish Date
October 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |