PIEZO ELECTRIC ULTRASONIC SCALER(LED)

GUDID 04719873120796

BONART CO., LTD.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 04719873120796
• NIH Device Record Key: 25a69748-50ef-4bc4-9289-a4f1a6e8e59c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIEZO ELECTRIC ULTRASONIC SCALER(LED)
• Version Model Number: ART-P6
• Company DUNS: 657263687
• Company Name: BONART CO., LTD.
• 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
GS1	04719873120796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071981

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[04719873120796]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-19

On-Brand Devices [PIEZO ELECTRIC ULTRASONIC SCALER(LED) ]

• 04719873121045: ART-P3II
• 04719873120796: ART-P6