METAL PRIMER

GUDID 00840479202136

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: 00840479202136
• NIH Device Record Key: b5f14045-6ddb-4d05-bdab-3575c72a0e68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: METAL PRIMER
• Version Model Number: ME
• 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	00840479202136 [Primary]
HIBCC	D798ME0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880766

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: 2026-03-18
• Device Publish Date: 2026-03-10

On-Brand Devices [METAL PRIMER]

• D798ME0: Reliance Metal Primer is intended for use as a conditioner of metal surfaces for bonding with an
• 00840479202136: ME