Cleared Traditional

K213562 - DTX Studio Clinic 3.0 (FDA 510(k) Clearance)

K213562 · Nobel Biocare AB · Radiology device

Mar 2022

Decision

136d

Days

Class 2

Risk

K213562 is an FDA 510(k) clearance for the DTX Studio Clinic 3.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Nobel Biocare AB (411 17 Goteborg, SE). The FDA issued a Cleared decision on March 25, 2022, 136 days after receiving the submission on November 9, 2021.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K213562 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 09, 2021
Decision Date	March 25, 2022
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF