PRO SEAL https://gudid.fda.gov/gudid/app/admin/udi/recordDe

GUDID 00840479200910

LED ProSeal

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: 00840479200910
• NIH Device Record Key: 92efe900-25e6-4233-90a4-5ee46292030e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO SEAL
• Version Model Number: PROSY
• Catalog Number: https://gudid.fda.gov/gudid/app/admin/udi/recordDe
• 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	00840479200910 [Primary]
HIBCC	D798PROSY0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021503

FDA Product Code

• EBD: Coating, Filling Material, 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: 2026-03-19
• Device Publish Date: 2026-03-11

Devices Manufactured by RELIANCE ORTHODONTIC PRODUCTS INC

• 00840479201481 - RENEW SYSTEM POINTS: 2026-03-23
• 00840479203614 - ULTRA VIOLET MINI LIGHT: 2026-03-23
• 00840479203621 - RETAINIUM LINGUAL RETENTION WIRE: 2026-03-23
• 00840479203652 - EXCEL REGULAR: 2026-03-23
• 00840479203669 - SYRINGE WING (1): 2026-03-23
• 00840479203249 - RETAINIUM LINGUAL RETENTION WIRE: 2026-03-20
• 00840479203256 - RETAINIUM LINGUAL RETENTION WIRE: 2026-03-20
• 00840479203263 - RETAINIUM LINGUAL RETENTION WIRE: 2026-03-20