DEVICE: 4/5/6mm Crown & Bridge Driver (D7850075NS0)

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Device Identifier (DI) Information

4/5/6mm Crown & Bridge Driver
4/5/6mm C&B Driver (Short)
0075NS
OCO BIOMEDICAL INC
D7850075NS0
HIBCC
1
4/5/6mm C&B Driver (Short) Places 4/5mm ISI C&B Implants and 4/5mm Solid Abutments for TSI/ERI/Macro
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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 implant system A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.
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FDA Product Code

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Product Code Product Code Name
DZN Instruments, Dental Hand
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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
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 Status

In Commercial Distribution
April 21, 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
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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
Yes
No
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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