DEVICE: Stain Colour 3D Transpa 1 (1 g) (D800MFAC1401)
Device Identifier (DI) Information
Stain Colour 3D Transpa 1 (1 g)
MFAC1401
In Commercial Distribution
ZIRKONZAHN SRL
MFAC1401
In Commercial Distribution
ZIRKONZAHN SRL
Content: 1 g Three-dimensional stain colours with special depth effect for surface colouring of full zirconia, ceramics and press ceramic. Stain and glaze firing can also be done in one step by working with the glazing mass directly on the case.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EIH | POWDER, PORCELAIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1356f71f-a173-44ec-9de9-42126f755c7d
July 24, 2018
3
November 04, 2016
July 24, 2018
3
November 04, 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
[?]
+390474066660
info@zirkonzahn.com
info@zirkonzahn.com