Zolar

GUDID 00628055817000

Zolar Technology & Mfg. Co. Inc.

Dental diode laser system

• Primary Device ID: 00628055817000
• NIH Device Record Key: 985ec6e0-eb88-49a7-bcf4-e270331fd396
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zolar
• Version Model Number: Photon
• Company DUNS: 250916892
• Company Name: Zolar Technology & Mfg. Co. 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055817000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122020

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

[00628055817000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-08-31

On-Brand Devices [Zolar]

• 00628055817017: Photon Plus
• 00628055817000: Photon