DEVICE: Henry Schein (00304040002179)
Device Identifier (DI) Information
Henry Schein
9009706
In Commercial Distribution
9009706
HENRY SCHEIN, INC.
9009706
In Commercial Distribution
9009706
HENRY SCHEIN, INC.
Zirlux ST1 95x14mm Disc
Device Characteristics
MR Safe | |
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EIH | POWDER, PORCELAIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141724 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Dry storage space |
Storage Environment Temperature: between 0 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 95 Millimeter |
Device Record Status
276975bb-55fd-473a-add5-6e92b7e04c9c
July 24, 2018
4
September 24, 2016
July 24, 2018
4
September 24, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined