Duns Number:439240722
Device Description: Device for laboratory use that allows to replicate the position and geometry of the attach Device for laboratory use that allows to replicate the position and geometry of the attachment positioned inside the printed model. The prosthetic structure is then created on it.
Catalog Number
144AVC5
Brand Name
OT EQUATOR-OT BRIDGE
Version/Model Number
ANALOG Ø5 W/SCREW FOR CAD/CAM MODEL
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
-
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
f0d240a7-00f8-4a02-873f-c0a10f679592
Public Version Date
February 22, 2021
Public Version Number
2
DI Record Publish Date
October 21, 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 |
|---|---|---|
| 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 |