DEVICE: ZZ BASE LK-BQ-WMSM-L15 QN (White Metal Scanmarker L15 with Screw) (D800ZBED15531L15)
Device Identifier (DI) Information
ZZ BASE LK-BQ-WMSM-L15 QN (White Metal Scanmarker L15 with Screw)
ZBED15531L15
In Commercial Distribution
ZIRKONZAHN SRL
ZBED15531L15
In Commercial Distribution
ZIRKONZAHN SRL
Compatible with LASAK BioniQ implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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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46122 | Dental implant suprastructure, temporary, preformed, reusable |
A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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NDP | Accessories, implant, dental, endosseous |
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
2bb90494-55f6-43e3-a248-337f1d0e0562
October 05, 2021
1
September 27, 2021
October 05, 2021
1
September 27, 2021
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