DentiMax

GUDID 00861572000306

DentiMax intraoral digital x-ray system, Size 1 Sensor.

DENTIMAX LLC

Dental digital imaging sensor, intraoral

• Primary Device ID: 00861572000306
• NIH Device Record Key: 6f479b32-0127-41bd-b38b-0a27c2d788ed
• Commercial Distribution Discontinuation: 2025-09-19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentiMax
• Version Model Number: Dream Sensor Size 1
• Company DUNS: 177893661
• Company Name: DENTIMAX LLC
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com
• Phone: (800) 704-8494
• Email: sales@dentimax.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861572000306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092547

FDA Product Code

• MUJ: System,Planning,Radiation Therapy Treatment

Sterilization

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

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

[00861572000306]

Liquid Chemical

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [DentiMax ]

• 00861572000313: DentiMax intraoral digital x-ray system, Size 2 Sensor.
• 00861572000306: DentiMax intraoral digital x-ray system, Size 1 Sensor.