DEVICE: EDENTA (E312DSB321524300UM1)
Device Identifier (DI) Information
EDENTA
DSB321.524.300UM
In Commercial Distribution
EDENTA ETABLISSEMENT
DSB321.524.300UM
In Commercial Distribution
EDENTA ETABLISSEMENT
Diamond Disc with sintered rim
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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34816 | Dental laboratory bur |
A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, a hard material (e.g., particles of diamond or tungsten carbide), and which is designed to fit into a dental laboratory handpiece that provides the rotation and that is intended for dental laboratory use only to cut hard structures (e.g., metals, plastics, porcelains), during the fabrication of dental restorations. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DZP | INSTRUMENT, DIAMOND, DENTAL |
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
f18b5a9a-8a14-4687-b868-92217e1fec6a
June 19, 2024
2
February 03, 2022
June 19, 2024
2
February 03, 2022
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