Duns Number:439240722
Device Description: Straight Titanium abutment H 3mm with passing holes, for temporary screwed prosthesis, wit Straight Titanium abutment H 3mm with passing holes, for temporary screwed prosthesis, with Titanium screw H 2 mm, white Seegers with handle and one Pink Seeger with handle
Catalog Number
MTE-100
Brand Name
OT EQUATOR - OT BRIDGE
Version/Model Number
IMPRESSION COPINGS 100 U.
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
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
36435d65-1bed-449a-be1e-f6d87e0ae7b7
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
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 |