DEVICE: Colour Liquid Prettau® Anterior® Aquarell D2 (50 ml) (D800FMAF4401)

Device Identifier (DI) Information

Colour Liquid Prettau® Anterior® Aquarell D2 (50 ml)
FMAF4401
In Commercial Distribution

ZIRKONZAHN SRL
D800FMAF4401
HIBCC

1
564251911 *Terms of Use
Content: 50 ml Colour Liquid for Prettau® Anterior® water-based and acid-free for brush and dipping technique. Warmer, less greyish colour shades. Every brushstroke before sintering is comprehensible through bio pigments. Use only in combination with metal-free brushes or metal-free tweezers.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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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
Dental articulation paste/solution A substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. 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
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Sterilization

No
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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

97ba1091-8510-4ce9-bd5f-9216abee5096
January 23, 2019
3
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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+390474066660
info@zirkonzahn.com
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