DentaLaze Kit DL001

GUDID E2352171B1

DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control & Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter, IFU, Box Oversleeve, Labels: box, fiber tips, charging stand, Danger sign

SHOFU DENTAL CORPORATION

General/multiple surgical diode laser system

• Primary Device ID: E2352171B1
• NIH Device Record Key: 900df90e-b156-4846-9ff8-eac8f15d3c1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaLaze Kit
• Version Model Number: DL001
• Catalog Number: DL001
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 10
• 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: 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

Customer Support Contacts

• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E2352171B1 [Unit of Use]
HIBCC	E235DL0010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201387

FDA Product Code

• NVK: Laser, Dental, Soft Tissue

Sterilization

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

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

[E2352171B1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-14
• Device Publish Date: 2023-06-06

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