DEVICE: Obsidian (D745701121OBP01071)

Device Identifier (DI) Information

Obsidian
70-1121-OBP0107
In Commercial Distribution
70-1121-OBP0107
James R. Glidewell, Dental Ceramics, Inc.
D745701121OBP01071
HIBCC

5
021228671 *Terms of Use
Obsidian Press A3 Press Over Metal 12mm/3g/5 Ingots
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental prosthesis 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 and is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EIH POWDER, PORCELAIN
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Weight: 3 Gram
CLOSE

Device Record Status

5bb3b748-f540-4ffc-baa8-4c1d4542537f
March 29, 2018
2
September 23, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D745701121OBP01070 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(949)440-2629
Shelly.Harris@glidewelldental.com
CLOSE