QD-J M4

GUDID 04560264568815

NAKANISHI INC.

Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler Pneumatic dental handpiece coupler

• Primary Device ID: 04560264568815
• NIH Device Record Key: 65f19e26-a8c1-4614-9b40-c2b4cb185b48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QD-J M4
• Version Model Number: QD-J M4
• 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	04560264568631 [Primary]
GS1	04560264568815 [Direct Marking]

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

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

Moist Heat or Steam Sterilization

[04560264568815]

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

On-Brand Devices [QD-J M4]

• 04560264573925: QD-J M4
• 04560264568815: QD-J M4