Kobayashi Tie Hooks SK12

GUDID D798SK121

Kobayashi Tie Hooks are intended for use to secure rubber bands to a bracket and elastics. This version is hook size .012. These are short wires.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic archwire/bracket ligature

• Primary Device ID: D798SK121
• NIH Device Record Key: 474f8916-0132-4ff2-a60e-e4e93690302a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kobayashi Tie Hooks
• Version Model Number: SK12
• Catalog Number: SK12
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient conditions.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798SK120 [Unit of Use]
HIBCC	D798SK121 [Primary]

FDA Product Code

• DZC: Wire, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-27

On-Brand Devices [Kobayashi Tie Hooks]

• D798UK141: Kobayashi Tie Hooks are Intended for the use of ligating archwires and hooks to orthodontic brac
• D798UK121: Kobayashi Tie hooks are intended for the use in ligating archwires and hooks to orthodontic brac
• D798SK121: Kobayashi Tie Hooks are intended for use to secure rubber bands to a bracket and elastics. This
• D798K141: Kobayashi Tie Hooks are Intended for the use of ligating archwires and hooks to orthodontic brac
• D798K121: Kobayashi Tie hooks are intended for the use in ligating archwires and hooks to orthodontic brac
• D798K101: Kobayashi Tie Hooks are intended for the use in ligating archwires and hooks to orthodontic brac
• D798SK100: Kobayashi Tie Hooks are intended for use to secure rubber bands to a bracket and elastics. This