Ti-Max

GUDID 04560264560383

NAKANISHI INC.

Pneumatic dental scaling/debridement system handpiece

• Primary Device ID: 04560264560383
• NIH Device Record Key: 1129a891-b9ea-4e75-8a6d-11c9af6ddd6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti-Max
• Version Model Number: S950L
• 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: false
• Serial Number: true
• 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	04560264560383 [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

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

Moist Heat or Steam Sterilization

[04560264560383]

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 [Ti-Max]

• 04560264560420: S950WL
• 04560264560413: S950SL
• 04560264560406: S950BL
• 04560264560390: S950KL
• 04560264560383: S950L
• 04560264560376: S950
• 04560224990151: S950WL
• 04560224990144: S950SL
• 04560224990137: S950BL
• 04560224989346: Ti-SG65L
• 04560224986499: Ti-SG20
• 04560224977527: S950KL
• 04560224977503: S950L
• 04560224977497: S950
• 04560224971129: Ti-SG20L
• 04560224972287: Ti-Max TIM40J