DEVICE: SIMPLANT® (07392532177064)

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Device Identifier (DI) Information

SIMPLANT®
37000
37000
Dentsply Implants NV
07392532177064
GS1
1
SIMPLANT Guide
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Surgical drill guide, single-use, sterile A sterile, hand-held, tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LLZ System, image processing, radiological
EBG CROWN AND BRIDGE, TEMPORARY, RESIN
DZE IMPLANT, ENDOSSEOUS, ROOT-FORM
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store at room temperature, do not expose to UV-light and moisture
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 30, 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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No
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)531-3481
implants-na-cs@dentsply.com
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