Duns Number:276075371
Device Description: Endodontic instrument for professionnal dental use only
Catalog Number
20114001
Brand Name
SMOOTH BROACH
Version/Model Number
n08 L21
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
-
Product Code
EKB
Product Code Name
Explorer, Operative
Public Device Record Key
0b3698e9-9c7d-4033-a2c8-e9f369f30726
Public Version Date
September 03, 2020
Public Version Number
1
DI Record Publish Date
August 26, 2020
Package DI Number
J015201140019
Quantity per Package
12
Contains DI Package
J015201140011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |