Duns Number:480420090
Device Description: Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is used to fill the endodontic cavity to result in complete sealing in order to prevent reoccurrence of pathologies in root canal which may occur if root canal is not obturated.Box of 100 pieces - Length 28mm
Catalog Number
-
Brand Name
GUTTA PERCHA POINT X-Large
Version/Model Number
24058
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EKM
Product Code Name
Gutta-Percha
Public Device Record Key
d5701c5e-6ae0-4580-9ab5-c730d6320383
Public Version Date
June 30, 2022
Public Version Number
1
DI Record Publish Date
June 22, 2022
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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |