Duns Number:275978864
Device Description: PACIFIC KITOPSC800: Ensuing the the passive fit between the conical abutment and the frame PACIFIC KITOPSC800: Ensuing the the passive fit between the conical abutment and the frameworkOPSC910 : Representing the clinical situation of a bonding ring secured to an implant onto a master cast for restoration planning by a dental technician.OPSC910 : Recreating a made to measure homothetic framework or castable bar
Catalog Number
-
Brand Name
Axiom
Version/Model Number
KITOPSC800
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
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
507353c9-ee0a-4c9b-a9a2-66d450cf634f
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
July 31, 2015
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. | 260 |