Duns Number:276075371
Device Description: Endodontic instrument for professional dental use only
Catalog Number
60029677
Brand Name
K-Reamers
Version/Model Number
N035 L31
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
EKP
Product Code Name
Reamer, Pulp Canal, Endodontic
Public Device Record Key
2baacea9-995b-4bcb-a7a9-c1cb91ab0268
Public Version Date
December 29, 2020
Public Version Number
1
DI Record Publish Date
December 21, 2020
Package DI Number
J015600296779
Quantity per Package
10
Contains DI Package
J015600296771
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 |