M800

GUDID 04560264559325

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 04560264559325
• NIH Device Record Key: 0c15b1b4-608f-480e-851c-33f1d8bda190
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M800
• Version Model Number: M800
• 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: true
• 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	04560264559325 [Direct Marking]
GS1	04560264570375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203791

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

[04560264559325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-01
• Device Publish Date: 2022-10-24

Devices Manufactured by NAKANISHI INC.

• 04589551383993 - Bur Stopper: 2024-11-21
• 04589551384006 - Bur Stopper Puller: 2024-11-21
• 04560264502963 - PTL Nozzle: 2024-11-11
• 04560264502970 - EZ-M4 Adaptor: 2024-11-11
• 04589551392063 - EZ SPRAY: 2024-11-11
• 04589551391950 - M205: 2024-10-24
• 04560264578586 - FX204 M4: 2024-10-24
• 04589551389391 - Surgic Pro2 OPT: 2024-10-23