DEVICE: Baltic Denture System BD Load (D7091032651)

Device Identifier (DI) Information

Baltic Denture System BD Load
Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs BL1 pink
In Commercial Distribution
1032651
Merz Dental GmbH
D7091032651
HIBCC

1
324914910 *Terms of Use
Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs BL1 pink
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Device Characteristics

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

GMDN

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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

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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

003d2303-46e1-438a-97c3-f01decc01a9d
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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