Cleared Traditional

K012505 - SOPRO595 INTRA ORAL CAMERA

K012505 is an FDA 510(k) clearance for SOPRO595 INTRA ORAL CAMERA, manufactured by Sopro. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K012505 · Sopro · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
63d
Days
Class 1
Risk

K012505 is an FDA 510(k) clearance for the SOPRO595 INTRA ORAL CAMERA. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sopro (Marseille, FR). The FDA issued a Cleared decision on October 5, 2001 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory 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 Sopro devices

FDA 510(k) Submission Details - K012505

510(k) Number K012505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2001
Decision Date October 05, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 66
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