Rely.a.Bond BIRPF

GUDID D798BIRPF0

Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Kit contains 2 x Rely A Bond Adhesive Paste Push syringes, 8g Primer with fluoride, 9 gm liquid etchant, mixing pad, mixing well, spatulas and brushes.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive Orthodontic bracket adhesive

• Primary Device ID: D798BIRPF0
• NIH Device Record Key: 31522431-fb7a-4d4b-9c84-3aa72bfc7010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rely.a.Bond
• Version Model Number: BIRPF
• Catalog Number: BIRPF
• 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: true
• 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	D798BIRPF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895521

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: 2018-09-21
• Device Publish Date: 2018-08-21

On-Brand Devices [Rely.a.Bond]

• D798RTF0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RPTHINF0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RPTHIN0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RPR0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RPJ0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RPF0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RP0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RJF0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798RJ0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D798BIRPF0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D7981RPPT0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke
• D7981RPP0: Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic bracke