Perfect A Smile PPA35

GUDID D798PPA350

Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. This patented formula works with clear thermoforming aligner plastics. It is not recommended for use with cloudy (C) thermoforming materials. This is a 4g jar of A3 Shade pontic paint.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental shaded pontic kit

• Primary Device ID: D798PPA350
• NIH Device Record Key: 0028e260-36ad-441b-aa51-220132c7628e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfect A Smile
• Version Model Number: PPA35
• Catalog Number: PPA35
• 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	D798PPA350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130237

FDA Product Code

• NXC: Aligner, Sequential

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: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [Perfect A Smile]

• D798PPB10: Perfect A Smile Pontic Paint is intended for use as a light cure coloring agent of thermoplastic
• D798PPA30: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Thi
• D798PPA20: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Th
• D798PASM0: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Thi
• D798PPD30: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Th
• D798PPC40: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Th
• D798PPC10: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Th
• D798PPBL0: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Th
• D798PPA350: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Th
• D798PPA10: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. Th