Cleared Traditional

K191616 - Orthophos S

K191616 is an FDA 510(k) clearance for Orthophos S, manufactured by Dentsply Sirona. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K191616 · Dentsply Sirona · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
28d
Days
Class 2
Risk

K191616 is an FDA 510(k) clearance for the Orthophos S. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on July 16, 2019 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Sirona devices

FDA 510(k) Submission Details - K191616

510(k) Number K191616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2019
Decision Date July 16, 2019
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 Peers - OAS X-ray, Tomography, Computed, Dental

All 95
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