Pro-Select3 S30701

GUDID D813S307010

PS3 Foot Pedal

DEN-MAT HOLDINGS, LLC

Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system

• Primary Device ID: D813S307010
• NIH Device Record Key: 6b06ee3e-9827-4f3a-bd5a-0b25599034b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Select3
• Version Model Number: S30701
• Catalog Number: S30701
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: true
• Serial Number: false
• 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: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use this product in presence of inflammable anesthetics or gases
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from explosive substances and flammable materials
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813S307010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964596

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[D813S307010]

High-level Disinfectant;Moist Heat or Steam Sterilization;Liquid Chemical

[D813S307010]

High-level Disinfectant;Moist Heat or Steam Sterilization;Liquid Chemical

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Pro-Select3]

• D813S307010: PS3 Foot Pedal
• D813S305500: PS3 6ft Autoclave Cable