COMPOSITE BITE TURBO GEL

GUDID 00840479200682

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: 00840479200682
• NIH Device Record Key: 681e472c-126c-49f1-97b9-9dffe6d44f65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPOSITE BITE TURBO GEL
• Version Model Number: 1TKOP
• 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	00840479200682 [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: 2026-03-03
• Device Publish Date: 2026-02-23

On-Brand Devices [COMPOSITE BITE TURBO GEL]

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