Naturally White

GUDID D769NWIAL0

Naturally White Aligner

PARK DENTAL RESEARCH CORP

Orthodontic progressive aligner

• Primary Device ID: D769NWIAL0
• NIH Device Record Key: 7648a4aa-9831-4a2e-a981-d340f7d84c6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Naturally White
• Version Model Number: NW-IAL
• Company DUNS: 011441508
• Company Name: PARK DENTAL RESEARCH CORP
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D769NWIAL0 [Primary]

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: 2024-08-06
• Device Publish Date: 2024-07-29

Devices Manufactured by PARK DENTAL RESEARCH CORP

• D76918040 - IMTEC: 2024-11-13 Basic Brower SGS
• D7690450100 - IMTEC: 2024-09-04 Combo Pack
• D769IMXP50100 - IMTEC: 2024-09-04 XP StarVent Implant w/ Cover Screw
• D769IM2511CO0 - IMTEC: 2024-08-29 Lew MDI Implant Collared
• D769IM2513CO0 - IMTEC: 2024-08-29 Lew MDI Implant Collared
• D769IM2513XO0 - IMTEC: 2024-08-29 Lew MDI Implant Non-Collared
• D769IM2515XO0 - IMTEC: 2024-08-29 Lew MDI Implant Non-Collared
• D769IM2517CO0 - IMTEC: 2024-08-29 Lew MDI Implant Collared