Duns Number:137217043
Device Description: CONTRA ANGLE (1/pack) Speed: Economical (20,000 RPM, Bearing: Sleeve; For more information CONTRA ANGLE (1/pack) Speed: Economical (20,000 RPM, Bearing: Sleeve; For more information: https://www.scottsdental.com/doriot-u-type-contra-angles.html
Catalog Number
135-1410
Brand Name
SCOTT'S 20K CONTRA ANGLE
Version/Model Number
135-1410
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGS
Product Code Name
Handpiece, contra- and right-angle attachment, dental
Public Device Record Key
0e44361a-fd52-40c8-b6e2-0c8b6b54319c
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 27, 2021
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 | 1050 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |