TKO Clear

GUDID D798TKOC0

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: D798TKOC0
• NIH Device Record Key: 55db7b3f-a6ae-4684-b5cb-dbdbbc8b35d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TKO Clear
• Version Model Number: TKOC
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798TKOC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210349

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [TKO Clear]

• D798TKOC0: TKOC
• D798TKOC150: TKOC
• D7981TKOC150: TKOC