PI01-R 55912

GUDID 04580406861314

OSADA ELECTRIC CO.,LTD.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 04580406861314
• NIH Device Record Key: 83b6905a-3eb0-40a5-bf29-c1fde9a1ad54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PI01-R
• Version Model Number: PI01-R
• Catalog Number: 55912
• Company DUNS: 690713813
• Company Name: OSADA ELECTRIC 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580406861314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844250

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04580406861314]

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: 2017-11-13

Devices Manufactured by OSADA ELECTRIC CO.,LTD.

• 04582227353498 - ST45: 2020-03-27
• 04580406860690 - ST38-90R: 2019-02-21
• 04580406860706 - ST38-90L: 2019-02-21
• 04580406860713 - ST38-90: 2019-02-21
• 04580406860720 - AP set 7: 2019-02-21
• 04580406860737 - AP point 1: 2019-02-21
• 04580406860744 - AP point 2: 2019-02-21
• 04580406860751 - AP point 3: 2019-02-21