ProSeal PRO

GUDID D798PRO0

PRO SEAL® and LED PRO SEAL® are intended for use as an enamel surface sealant around orthodontic brackets. 6ml bottle ProSeal

RELIANCE ORTHODONTIC PRODUCTS INC

Dental pit/fissure sealant

• Primary Device ID: D798PRO0
• NIH Device Record Key: 21a06a9d-e546-4b21-9dfd-ab46e7596b55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSeal
• Version Model Number: PRO
• Catalog Number: PRO
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798PRO0 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-15

On-Brand Devices [ProSeal]

• D798PRO0: PRO SEAL® and LED PRO SEAL® are intended for use as an enamel surface sealant around orthodont
• D798LEDPRO0: LED PRO SEAL® is intended for use as an enamel surface sealant around orthodontic brackets. L
• D798PROSY0: ProSeal
• D7981PROSY0: ProSeal