DEVICE: Obsidian (D745701121OBP01461)
Device Identifier (DI) Information
Obsidian
70-1121-OBP0146
In Commercial Distribution
70-1121-OBP0146
Prismatik Dentalcraft, Inc
70-1121-OBP0146
In Commercial Distribution
70-1121-OBP0146
Prismatik Dentalcraft, Inc
Obsidian Press BL4 Press Over Metal 12mm/6g/3 Ingots
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
16187 | Dental appliance fabrication material, ceramic |
A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EIH | POWDER, PORCELAIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141887 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Weight: 6 Gram |
Device Record Status
fbe9e6fd-8bb0-4869-b60a-739cbb9cc1d5
August 22, 2023
5
September 23, 2016
August 22, 2023
5
September 23, 2016
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:
D745701121OBP01460
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(949)440-2629
Shelly.Harris@glidewelldental.com
Shelly.Harris@glidewelldental.com