Precedent PRL15

GUDID D798PRL150

Precedent® is intended for use as an orthodontic band cement. Precedent 15cc Liquid

RELIANCE ORTHODONTIC PRODUCTS INC

Glass ionomer dental cement

• Primary Device ID: D798PRL150
• NIH Device Record Key: 0caf6685-ea34-40e1-894f-9f2c0a69a9f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precedent
• Version Model Number: PRL15
• Catalog Number: PRL15
• 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	D798PRL150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934405

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 [Precedent]

• D798PRS0: Precedent® is intended for use as an orthodontic band cement. Kit contains: 15g Precedent® Pow
• D798PRP150: Precedent® is intended for use as an orthodontic band cement. 15g Precedent® Powder
• D798PRP1000: Precedent® is intended for use as an orthodontic band cement. This is the 100g Precedent Powde
• D798PRL150: Precedent® is intended for use as an orthodontic band cement. Precedent 15cc Liquid
• D798PRE0: Precedent® is intended for use as an orthodontic band cement. Kit contains: 100g Precedent® Po
• D7981PRL300: Precedent® is intended for use as an orthodontic band cement. Precedent 30cc Liquid