TKO

GUDID D798TKOP0

Composite Bite Turbo Gel Pink - Contains one 3.4g syringe with 5 tips

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: D798TKOP0
• NIH Device Record Key: 16dbf7da-8ac1-42d1-9ea6-91ab693b2ce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TKO
• Version Model Number: TKOP
• 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	D798TKOP0 [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: 2021-10-20
• Device Publish Date: 2021-10-12

Devices Manufactured by RELIANCE ORTHODONTIC PRODUCTS INC

• D7981TKOC150 - TKO Clear: 2024-08-09
• D798TKOC150 - TKO Clear: 2024-08-09
• D79821BTIPS101 - Brush Tips: 2023-12-21
• D798RBTA0 - Tweezers: 2023-12-21
• D798RBTP0 - Tweezers: 2023-12-21
• D798RBX0 - ReliaBox: 2023-12-21 ReliaBox
• D798RBXK0 - ReliaBox: 2023-12-21 ReliaBox Kit
• D7981BEGSSAM0 - Gel Etchant: 2023-09-27