Duns Number:054875224
Device Description: BioHorizons 4.5mm – Milled Ti AbutmentKit contains:1 BioHorizons 4.5mm – Milled Ti Abutm BioHorizons 4.5mm – Milled Ti AbutmentKit contains:1 BioHorizons 4.5mm – Milled Ti Abutment2 Biohorizons 3.5mm/4.5mm Titanium Screws
Catalog Number
9005567-F
Brand Name
Preat Implant Prosthetics
Version/Model Number
9005567-F
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
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
c1eb0a09-ce9d-4f6f-a344-b00319dd2d2d
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
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 | 958 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1846 |