AIR SCALER TIP

GUDID 04560264562189

NAKANISHI INC.

Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable

• Primary Device ID: 04560264562189
• NIH Device Record Key: 3ad1cf7a-501e-4114-9b95-8640eef16217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR SCALER TIP
• Version Model Number: S21R
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 1
• DM Exempt: true
• 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	04560264562189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991021

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

[04560264562189]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-16

On-Brand Devices [AIR SCALER TIP]

• 04560264562349: S35
• 04560264562233: S75
• 04560264562226: S2
• 04560264562219: S3
• 04560264562202: S1
• 04560264562196: S21L
• 04560264562189: S21R
• 04560264562172: S20
• 04560264562165: S10