DEVICE: Kobayashi Tie Hooks (D798SK141)

Device Identifier (DI) Information

Kobayashi Tie Hooks
SK14
In Commercial Distribution
SK14
RELIANCE ORTHODONTIC PRODUCTS INC
D798SK141
HIBCC

100
113170088 *Terms of Use
Kobayashi Tie Hooks are intended for use to secure rubber bands to a bracket and elastics. This version is hook size .014 with short wire length.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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
Orthodontic archwire/bracket ligature A device intended to hold an orthodontic archwire securely in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie or circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).
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FDA Product Code

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Product Code Product Code Name
DZC Wire, Orthodontic
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store at ambient conditions.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

722ea157-e3d6-4c76-bcde-9d159c920234
March 29, 2018
2
July 27, 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: D798SK140 CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
630-773-4009
paulgropi@aol.com
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