DEVICE: Prettau® Anterior® T0 Zirconia 95H10 (D800ZRFA8001)

Device Identifier (DI) Information

Prettau® Anterior® T0 Zirconia 95H10
ZRFA8001
In Commercial Distribution

ZIRKONZAHN SRL
D800ZRFA8001
HIBCC

1
564251911 *Terms of Use
Content: 1 piece Height: 10 mm Extremely transparent zirconia for single crowns, inlays, onlays, veneers and max. 3-unit bridges (fully anatomic or reduced structures for ceramic layering).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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No
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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 bridge, ceramic A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.
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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
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

a97d490e-1b07-4478-b722-d7a8a01a5258
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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+390474066660
info@zirkonzahn.com
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