AeroPro Cordless Prophy System 5500520

GUDID D691550005200

AeroPro Sterilizable Outer Sheath

PREMIER DENTAL PRODUCTS COMPANY

Dental power tool system handpiece, battery-powered

• Primary Device ID: D691550005200
• NIH Device Record Key: 515ec70d-b826-46d3-add4-77818b9df2f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroPro Cordless Prophy System
• Version Model Number: AP-18-PDPC
• Catalog Number: 5500520
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: 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: 610-239-6000
• Email: info@premierdentalco.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D691550005200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180682

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D691550005200]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-18
• Device Publish Date: 2020-03-10

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