DEVICE: ASTRA TECH Implant System® (07392532067242)
Device Identifier (DI) Information
ASTRA TECH Implant System®
24564
In Commercial Distribution
24564
Dentsply Implants Manufacturing GmbH
24564
In Commercial Distribution
24564
Dentsply Implants Manufacturing GmbH
Direct Abutment API™ 4.5/5.0 - Ø 6, 4 mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
Yes | |
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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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44881 | Dental implant suprastructure kit |
A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
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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Special Storage Condition, Specify: Storage in the original packaging, in a dry place, at normal room temperature. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
51811054-4106-468f-a69a-82106078fb5e
March 29, 2018
2
October 16, 2015
March 29, 2018
2
October 16, 2015
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 |
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
[?]
+1(800)531-3481
implants-na-cs@dentsply.com
implants-na-cs@dentsply.com