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 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