Phase II PJAF

GUDID D798PJAF0

Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. 1 X 18g Phase II Adhesive Paste A with Fluoride in jar

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive Orthodontic bracket adhesive

• Primary Device ID: D798PJAF0
• NIH Device Record Key: a8e20339-4c4d-40c9-89b2-842913bc3e7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phase II
• Version Model Number: PJAF
• Catalog Number: PJAF
• 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 C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 C).

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798PJAF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895523

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: 2016-08-17

On-Brand Devices [Phase II]

• D798PSF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PJMCFF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PJMCF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PJF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PJB0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PJAF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PJA0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PESF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798PEJF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798EUPS0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798EUPJ0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D798DCSF0: PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bond
• D798DCJF0: PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bond
• D798DCJAF0: PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bond
• D7981PSB0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D7981PSAF0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc
• D7981PSA0: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and applianc