Cleared Traditional

K153710 - Tuxedo Digital Dental Sensor
(FDA 510(k) Clearance)

K153710 · Led Dental, Inc. · Radiology

Mar 2016

Decision

85d

Days

Class 2

Risk

K153710 is an FDA 510(k) clearance for the Tuxedo Digital Dental Sensor. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB).

Submitted by Led Dental, Inc. (Burnaby, CA). The FDA issued a Cleared decision on March 18, 2016, 85 days after receiving the submission on December 24, 2015.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K153710 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 24, 2015
Decision Date	March 18, 2016
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF