Integra™ D680110

GUDID M595D6801100

110v Integra™ Ultrasonic Scaling System

PARKELL, INC.

Ultrasonic dental scaling/debridement system

• Primary Device ID: M595D6801100
• NIH Device Record Key: 7f38f3b4-8be0-49b1-a4af-523cee873c33
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra™
• Version Model Number: D680110
• Catalog Number: D680110
• Company DUNS: 009900424
• Company Name: PARKELL, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595D6801100 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[M595D6801100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-09-23

On-Brand Devices [Integra™]

• 00810000520299: 110v Integra™ Ultrasonic Scaling System
• M595D6811: Replacement Reservoir Bottles for Integra™ Scaler (2 Bottles & Caps)
• M595D6801100: 110v Integra™ Ultrasonic Scaling System
• 00810000520305: 230-volt Integra™ Ultrasonic Scaling System
• 10810000520319: Replacement Reservoir Bottles for Integra™ Scaler (2 Bottles & Caps)