Axeos

X-ray, Tomography, Computed, Dental

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Axeos.

Pre-market Notification Details

• Device ID: K201140
• 510k Number: K201140
• Device Name: Axeos
• Classification: X-ray, Tomography, Computed, Dental
• Applicant: Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401
• Contact: Karl J. Nittinger
• Correspondent: Karl J. Nittinger; Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401
• Product Code: OAS
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-29
• Decision Date: 2020-06-22