Duns Number:487506230
Device Description: 05001409 CM LOC® Abutment Straumann® RN 4.8 GH2 35Ncm. The CM LOC® is used for the followi 05001409 CM LOC® Abutment Straumann® RN 4.8 GH2 35Ncm. The CM LOC® is used for the following clinical situations:• CM LOC® Abutment: Implant anchorage of hybrid-supported removable dental prostheses on implants.• CM LOC® CAD CAM Retention Element: As an additional retaining element on CAD CAM milled dental bars.• divergence up to 30 degrees per implant with CM LOC®
Catalog Number
05001409
Brand Name
CM LOC®
Version/Model Number
05001409
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
K130618
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
c316c084-763b-4a41-847a-266d3eefdb04
Public Version Date
November 08, 2019
Public Version Number
6
DI Record Publish Date
February 20, 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 | 208 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 535 |