Duns Number:054875224
Device Description: Straumann Bone Level RC Engaging Verification CylinderKit contains:1 Straumann Bone Level Straumann Bone Level RC Engaging Verification CylinderKit contains:1 Straumann Bone Level RC Engaging Verification Cylinder (00842092125717)1 Straumann Bone Level RC Guide Pin 20mm (00842092133774)1 Straumann Bone Level RC Titanium Screw (00842092165959)
Catalog Number
9001430-10
Brand Name
Implant Prosthetics
Version/Model Number
9001430-10
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
K183518,K183518
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
d2bb41de-a0c2-4711-85c0-d36a963722ad
Public Version Date
October 19, 2022
Public Version Number
2
DI Record Publish Date
September 06, 2022
Package DI Number
00842092165980
Quantity per Package
10
Contains DI Package
00842092165973
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 958 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1846 |