DEVICE: Baltic Denture System BD Load (D7091032658)

Device Identifier (DI) Information

Baltic Denture System BD Load
Baltic Denture System BDLoad Mw7 PLSEbim6DFm BL1 pink
In Commercial Distribution
1032658
Merz Dental GmbH
D7091032658
HIBCC

1
324914910 *Terms of Use
Baltic Denture System BDLoad Mw7 PLSEbim6DFm BL1 pink
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
EKO Denture Preformed (Partially Prefabricated Denture)
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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

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Size Type Text
No Device Sizes
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Device Record Status

93e5d7bd-83cf-4815-93ca-c25f602bece4
March 29, 2018
2
December 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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

[?]
+494381403411
claudia.bobrowski@merz-dental.de
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