TuxDeluxe (Size 1 6100B, Size 2 6101B)— 510(k) K232552

Substantially Equivalent

Tuxedo Imaging, LLC

FDA 510(k) clearance K232552 for TuxDeluxe (Size 1 6100B, Size 2 6101B), Substantially Equivalent on 2023-10-20. Applicant: Tuxedo Imaging, LLC. Device class: 2.

Clearance details

Applicant
Tuxedo Imaging, LLC
Product code
Code MUH
Device class
Class 2
Regulation
21 CFR 872.1800
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Akron, OH, US
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