Duns Number:009831413
Device Description: Quala B1 Temporary C & B 10:1 Cartridge
Catalog Number
Q85805
Brand Name
Quala
Version/Model Number
Q85805
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
K102753
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
bd96067a-388b-4c7b-9f82-fad67bd95387
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 2017
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 | 224 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |