Duns Number:137217043
Device Description: GUTTA PERCHA POINTS (100/box) Type: PT Taper, Size: F1; For more information: https://www. GUTTA PERCHA POINTS (100/box) Type: PT Taper, Size: F1; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
Catalog Number
103-9188
Brand Name
SCOTT'S GUTTA PERCHA P-TAPER 100/bx CC # F1
Version/Model Number
103-9188
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKM
Product Code Name
GUTTA-PERCHA
Public Device Record Key
7e9385f0-a8d7-4294-a3f3-54d0a384c078
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 |