DEVICE: StecoTitanmagnetics® (ESTOU0001Z3150)

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Device Record History
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Device Identifier (DI) Information
StecoTitanmagnetics®
U.00.01.Z315
In Commercial Distribution
U.00.01.Z315
steco-System-Technik GmbH & Co KG
ESTOU0001Z3150
HIBCC

1
389566209 *Terms of Use
Titanmagnetics® denture magnet Z-Line D5.8/H3.15 universal -> For further information visit steco.de
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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?
38578 Magnetic dental precision attachment
A device with magnetic properties designed for fixation of a removable dental prosthesis.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EGG Attachment, Precision, All
KCZ Prosthesis, Breast, External, Used With Adhesive
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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
No Device Sizes
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Device Record Status
c10f9a98-37a3-47c7-b2c7-482f8c63d6c0
April 15, 2019
2
March 26, 2018
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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

[?]
+49405577810
info@steco.de
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