PM-L

GUDID 04560224977268

NAKANISHI INC.

Dental abrasive air jet system handpiece

• Primary Device ID: 04560224977268
• NIH Device Record Key: ac60f079-7596-42cf-9f83-05e6c5d74278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PM-L
• Version Model Number: PM-L
• 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	04560224977268 [Primary]
GS1	04589551382934 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032395

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

[04560224977268]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-03
• Device Publish Date: 2020-06-25

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• 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