M3II TRANSFORMER -115V

GUDID 04719873120970

BONART CO., LTD.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 04719873120970
• NIH Device Record Key: fe5faab0-6fae-43dc-869b-a0189fc69da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M3II TRANSFORMER -115V
• Version Model Number: GP0006-291R
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	04719873120970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052028

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-15

Devices Manufactured by BONART CO., LTD.

• 04719873121533 - ART TRIPLE BEND 25kHz: 2023-04-03
• 04719873121540 - ART TRIPLE BEND 30kHz: 2023-04-03
• 04719873121410 - PIEZO TIP/BE-P: 2022-03-28
• 04719873121366 - 25K FS-SLIM PLASTIC INSERT/Darby: 2021-01-04
• 04719873121373 - 30K FS-SLIM PLASTIC INSERT/Darby: 2021-01-04
• 04719873121380 - 25K FS-10 PLASTIC INSERT/Darby: 2021-01-04
• 04719873121397 - 30K FS-10 PLASTIC INSERT/Darby: 2021-01-04
• 04719873121359 - BONE TIP/BM-PS1: 2020-09-25