Cleared Traditional

DTX Studio Clinic (4.0)

K231898 · Nobel Biocare AB · Radiology
Dec 2023
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K231898 is an FDA 510(k) clearance for the DTX Studio Clinic (4.0), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Nobel Biocare AB (G?teborg, SE). The FDA issued a Cleared decision on December 8, 2023, 163 days after receiving the submission on June 28, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K231898 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2023
Decision Date December 08, 2023
Days to Decision 163 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050