DEVICE: ASTRA TECH Implant System® EV (07392532144356)

Device Identifier (DI) Information

ASTRA TECH Implant System® EV
25368
In Commercial Distribution
25368
Dentsply Implants Manufacturing GmbH
07392532144356
GS1

1
344038836 *Terms of Use
Direct Abutment™ EV 4.2 Ø 5 - 2 mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
42354 Transgingival implant
A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
DZE IMPLANT, ENDOSSEOUS, ROOT-FORM
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Storage in the original packaging, in a dry place, at normal room temperature.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5b2de8c3-4cb3-4d77-be83-a02976660cfb
March 29, 2018
2
October 24, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)531-3481
implants-na-cs@dentsply.com
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