Duns Number:083235549
Device Description: Caulk Super Bur 10-Pack - Size 557SS FG
Catalog Number
665746
Brand Name
Caulk® Super Bur®
Version/Model Number
665746
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
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
-
Product Code
EJL
Product Code Name
BUR, DENTAL
Public Device Record Key
d0c0f3e4-a91f-4713-811c-3f07e06352a9
Public Version Date
March 23, 2020
Public Version Number
2
DI Record Publish Date
April 02, 2019
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 | 123 |
2 | A medical device with a moderate to high risk that requires special controls. | 397 |
U | Unclassified | 2 |