Duns Number:439240722
Device Description: Dental instruments designed for the placement and construction of a dental prostheses.
Catalog Number
-
Brand Name
RHEIN 83 TOOLS
Version/Model Number
INSTRUMENT SET (CAI)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 22, 2020
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
e446badc-419e-43fb-9b6e-5ab593cd4e4f
Public Version Date
December 22, 2020
Public Version Number
3
DI Record Publish Date
May 29, 2018
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 | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |