DEVICE: Colour Liquid Aquarell Bio-Pigment Tissue (10 ml) (D800FMAD0020)

Device Identifier (DI) Information

Colour Liquid Aquarell Bio-Pigment Tissue (10 ml)
FMAD0020
In Commercial Distribution

ZIRKONZAHN SRL
D800FMAD0020
HIBCC

1
564251911 *Terms of Use
Content: 10 ml Burn-out pigments for freshening up Colour Liquid Prettau® Aquarell Tissue A-C
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Dental articulation liquid A solution used to characterize the contact relationship of the occlusal surfaces between the maxillary and the mandibular teeth. It typically consists of a binary liquid system that includes primary liquid compound that is partially absorbed by the teeth and a second liquid compound that may be either applied to the teeth to show on the actual teeth the contact surfaces or on a substrate that shows visible marks when the patient bites. It is used in a variety of dental tests, such as the determination of size, shape, and proper placement of partial dentures and to program and/or assess progress of orthodontic treatment. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EIH POWDER, PORCELAIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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

53f5b68d-fb7d-4872-a302-831086ff4124
March 29, 2018
2
November 04, 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
Yes
No CLOSE

Customer Contact

[?]
+390474066660
info@zirkonzahn.com
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