THERMA CURE

GUDID 00840479203485

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: 00840479203485
• NIH Device Record Key: 939a916e-be19-4f23-8aa1-09dee1f011aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERMA CURE
• Version Model Number: TC
• 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	00840479203485 [Primary]
HIBCC	D798TC0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071590

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, 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: 2026-03-02
• Device Publish Date: 2026-02-20

On-Brand Devices [THERMA CURE]

• D798TC0: Therma-Cure is intended for use as a heat curable adhesive for indirect bonding.
• 00840479203485: TC