PORTODENT

GUDID B234JCXPD101125115

PD-II 115V WITH AMALGAM SEPARATOR

CPAC EQUIPMENT, INC.

Dental suction system

• Primary Device ID: B234JCXPD101125115
• NIH Device Record Key: 5e597cd0-84e6-4605-a675-765f18e5385a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTODENT
• Version Model Number: 101125
• Company DUNS: 601985976
• Company Name: CPAC EQUIPMENT, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B234JCXPD101125115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K771071

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

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: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [PORTODENT]

• B234JCXPD101125115: PD-II 115V WITH AMALGAM SEPARATOR
• B234JCXPD101009230: PD-II 230V MODEL
• B234JCXPD101008115: PD-II 115V MODEL