DEVICE: MEDENTiKA (04251574813800)

Device Identifier (DI) Information

MEDENTiKA
EV 62
In Commercial Distribution
EV 62
MEDENTiKA GmbH
04251574813800
GS1

1
537555497 *Terms of Use
Abutment screw
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Device Characteristics

MR Conditional
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?
61647 Dental prosthesis/implant abutment screw
A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NHA Abutment, implant, dental, endosseous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K223113 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Abutment screw / Hex 1,26 M 1,8
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Device Record Status

b0694976-49a0-4ffe-90a9-90eade52c648
May 09, 2024
1
May 01, 2024
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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
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)448-8168
Info.usa@straumann.com
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