DEVICE: Z5m(t) (07540166760559)

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Device Identifier (DI) Information

Z5m(t)
Z5m(t)-50-12
Z5m(t)-50-12
Z SYSTEMS USA INCORPORATED
07540166760559
GS1
1
Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-12
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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
Screw endosteal dental implant, one-piece A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.
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FDA Product Code

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Product Code Product Code Name
DZE Implant, Endosseous, Root-Form
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Sterilization

Yes
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
Length: 12 Millimeter
Outer Diameter: 5 Millimeter
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Device Status

In Commercial Distribution
August 25, 2015

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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

[?]
+41623886969
support@zsystems.com
(877) 874 9407
usa@zsystems.com
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