Cleared Traditional

K221921 - DTX Studio Clinic 3.0

K221921 is the FDA 510(k) clearance for DTX Studio Clinic 3.0 by Nobel Biocare AB. It is a Class 2 Radiology device (product code MYN) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K221921 · Nobel Biocare AB · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
270d
Days
Class 2
Risk

K221921 is an FDA 510(k) clearance for the DTX Studio Clinic 3.0. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Nobel Biocare AB (411 17 Goteborg, SE). The FDA issued a Cleared decision on March 28, 2023 after a review of 270 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nobel Biocare AB devices

Submission Details

510(k) Number K221921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date March 28, 2023
Days to Decision 270 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 107d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Nobel Biocare C/O Medicim NV
Wim Vrydag

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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