DEVICE: Genesis ACTIVE (D768GA220170)
Device Identifier (DI) Information
Genesis ACTIVE
GA22017
In Commercial Distribution
KEYSTONE DENTAL, INC.
GA22017
In Commercial Distribution
KEYSTONE DENTAL, INC.
Genesis Active Conical Healing Abutment, Concave, Ø6.0, H3.0mm
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44880 | Dental implant suprastructure, temporary, preformed, single-use |
A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHA | Abutment, implant, dental, endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K223814 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep out of sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 3.0 Millimeter |
Outer Diameter: 6.0 Millimeter |
Device Record Status
6bc3545a-f598-4950-a081-ef25cd4fef5f
June 27, 2023
1
June 19, 2023
June 27, 2023
1
June 19, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)902-9272
customersupport@keystonedental.com
customersupport@keystonedental.com