DEVICE: Polystar Selection EDITION / Polystar Selection EDITION HD (D7091010337)

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Device Record History
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Device Identifier (DI) Information
Polystar Selection EDITION / Polystar Selection EDITION HD
Living mould chart Polystar Selection EDITION / Polystar Selection EDITION HD A3
In Commercial Distribution
1010337
Merz Dental GmbH
D7091010337
HIBCC

1
324914910 *Terms of Use
Living mould chart Polystar Selection EDITION / Polystar Selection EDITION HD in shade A3 containing: 21 upper and 9 lower anteriors sets, 4 upper and 4 lower posteriors sets, 4 upper and 4 lower HD posterior sets
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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?
38643 Resin artificial teeth
Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ELM Denture, Plastic, Teeth
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
e58dbe0c-decd-4bff-a074-0822eb14c5e2
September 09, 2025
1
September 01, 2025
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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
No
No CLOSE

Customer Contact

[?]
+4943814030
regulatory@merz-dental.de
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