Orchestrate 3D

GUDID D769O3D0

Orthodontic Software

PARK DENTAL RESEARCH CORP

CAD/CAM software

• Primary Device ID: D769O3D0
• NIH Device Record Key: 10b095c6-73ca-4bf7-a2d0-1d30e7b4d51d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orchestrate 3D
• Version Model Number: O3D
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D769O3D0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181112

FDA Product Code

• PNN: Orthodontic Software

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: 2025-07-25
• Device Publish Date: 2025-07-17

Devices Manufactured by PARK DENTAL RESEARCH CORP

• D769O3D0 - Orchestrate 3D: 2025-07-25Orthodontic Software
• D769O3D0 - Orchestrate 3D: 2025-07-25 Orthodontic Software
• D76980281 - IMTEC: 2025-05-22 Dispensing Gun
• D769IMP90230 - IMTEC: 2025-05-22 2.0/3.3mm Paralleling Pins
• D769IMP9025DL0 - IMTEC: 2025-05-22 StarVent MT Latch Driver
• D769IMP90450 - IMTEC: 2025-05-22 3.75/4.2mm Paralleling Pin
• D769IMXP9025DL0 - IMTEC: 2025-05-22 StarVent XP Latch Driver
• D769JGUN10 - IMTEC: 2025-05-22 Univisal Dispensing Gun
• D76987010 - IMTEC: 2025-05-21 Mixing Tips