DEVICE: Obsidian (D745701121OBP01471)

Device Identifier (DI) Information

Obsidian
70-1121-OBP0147
In Commercial Distribution
70-1121-OBP0147
James R. Glidewell, Dental Ceramics, Inc.
D745701121OBP01471
HIBCC

3
021228671 *Terms of Use
Obsidian Press A1 15mm/8g/3 Ingots GD
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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 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.
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FDA Product Code

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Product Code Product Code Name
EIH POWDER, PORCELAIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141887 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Weight: 8 Gram
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Device Record Status

5dcbfa88-bb39-46ee-9a6c-33cbd38b41db
July 24, 2018
4
September 23, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D745701121OBP01470 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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