Duns Number:004584361
Device Description: Regular Ti Healing Abutment, 4 mm. For Biomet 3i Certain Internal 4.1 mm Platform 1, 2 and Regular Ti Healing Abutment, 4 mm. For Biomet 3i Certain Internal 4.1 mm Platform 1, 2 and 3 mm GH Abutments
Catalog Number
HT35010BMI41
Brand Name
Smileloc® BY RODO
Version/Model Number
HT35010BMI41
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
K193274
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
51515124-811a-47f8-b4bd-4c665f942f27
Public Version Date
August 12, 2020
Public Version Number
1
DI Record Publish Date
August 04, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 272 |