DEVICE: ASTRA TECH Implant System® EV (07392532133817)
Device Identifier (DI) Information
ASTRA TECH Implant System® EV
25284
In Commercial Distribution
25284
Dentsply Implants Manufacturing GmbH
25284
In Commercial Distribution
25284
Dentsply Implants Manufacturing GmbH
Cover Screw EV 5.4
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. 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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Storage in the original packaging, in a dry place, at normal room temperature. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e9a5dbe9-440f-498e-b2bd-1ffdcf8b518b
April 29, 2021
4
October 31, 2015
April 29, 2021
4
October 31, 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 |
---|---|
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