COMPOSITE BITE TURBO GEL

GUDID 00840479200675

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: 00840479200675
• NIH Device Record Key: 4cc27254-e140-41dd-aea0-675fa2b01717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPOSITE BITE TURBO GEL
• Version Model Number: 1TKOC15
• 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
GS1	00840479200675 [Primary]
HIBCC	D7981TKOC150 [Previous]

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: 2026-03-03
• Device Publish Date: 2026-02-23

On-Brand Devices [COMPOSITE BITE TURBO GEL]

• 00840479200699: 1TKOPLV
• 00840479200682: 1TKOP
• 00840479200675: 1TKOC15
• 00840479200668: 1TKOC