DEVICE: Baltic Denture System BD Load (D7091032617)
Device Identifier (DI) Information
Baltic Denture System BD Load
Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs D3 light pink
In Commercial Distribution
1032617
Merz Dental GmbH
Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs D3 light pink
In Commercial Distribution
1032617
Merz Dental GmbH
Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs D3 light pink
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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No | |
No | |
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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? |
---|---|---|---|---|
11172 | Preformed complete denture |
A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EKO | Denture Preformed (Partially Prefabricated Denture) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cc97585c-5f9e-44ba-bca2-b94c522eecdb
March 29, 2018
2
December 15, 2016
March 29, 2018
2
December 15, 2016
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 |
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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
[?]
+494381403411
claudia.bobrowski@merz-dental.de
claudia.bobrowski@merz-dental.de