DEVICE: Countersink Drill (D78540CSD0)

Device Identifier (DI) Information

Countersink Drill
4mm Countersink Drill
In Commercial Distribution
4.0 CS
OCO BIOMEDICAL INC
D78540CSD0
HIBCC

1
094146123 *Terms of Use
4.0mm Countersink Drill 4mm Diameter For ISI/TSI/ERI Implants (not always required)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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
Fixture/appliance dental drill bit, reusable A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
DZA Drill, Dental, Intraoral
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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 Record Status

d6176ae0-d59a-4263-a15a-5de7959ce7de
November 22, 2018
3
April 22, 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
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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