ULTRA SELF ETCHING PRIMER

GUDID 00840479203607

RELIANCE ORTHODONTIC PRODUCTS INC

Dental tooth-etching solution

• Primary Device ID: 00840479203607
• NIH Device Record Key: dc6c397c-4606-4615-afcd-1c9c46bf3cca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA SELF ETCHING PRIMER
• Version Model Number: USEP2ML
• 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	00840479203607 [Primary]
HIBCC	D798USEP2ML0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210945

FDA Product Code

• KLE: Agent, Tooth Bonding, 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 [ULTRA SELF ETCHING PRIMER]

• 00840479203607: USEP2ML
• 00840479203591: USEP