Perio-Control Tips

GUDID 04560264563780

NAKANISHI INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 04560264563780
• NIH Device Record Key: 7a633c27-52cc-4436-a834-bb7660c3af4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perio-Control Tips
• Version Model Number: Perio-Control Tips Starter Kit
• Company DUNS: 690710546
• Company Name: NAKANISHI 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264563780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113530

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264563780]

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: 2016-09-16

On-Brand Devices [Perio-Control Tips]

• 04560264563780: Perio-Control Tips Starter Kit
• 04560264563773: Perio-Control Tips Starter Kit(V10-E Set)
• 04560264562356: Perio-Control Tips Air Scaler Kit