Rely.a.Bond RPTHINF

GUDID D798RPTHINF0

Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Kit contains 14g Thin Viscosity Rely A Bond Adhesive Paste in push Syringes, 16g Primer with fluoride, liquid etchant 9g, mixing pad, spatulas and brushes. Thin Viscosity Kit with Fluoride.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: D798RPTHINF0
• NIH Device Record Key: 4f6c0b9f-13b8-454a-97d5-51d139857226
• Commercial Distribution Discontinuation: 2017-12-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rely.a.Bond
• Version Model Number: RPTHINF
• Catalog Number: RPTHINF
• 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)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798RPTHINF0 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-15

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