Duns Number:439240722
Device Description: DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection a DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection and the thread are compatible with the specific implant; available in different cuff heights. Retentive caps of different retentive forces, metal housing for the caps and protective disc.
Catalog Number
131NAC352
Brand Name
OT EQUATOR - OT BRIDGE
Version/Model Number
OT EQUATOR NOBEL ACTIVE NP ø3,5 h.2 c/SB
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
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
5af83c38-251c-4c78-87fb-b9f0a9307c63
Public Version Date
July 19, 2021
Public Version Number
1
DI Record Publish Date
July 09, 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 |