Cleared Traditional

K012529 - ROK

K012529 is an FDA 510(k) clearance for ROK, manufactured by Southern Dental Industries, Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K012529 · Southern Dental Industries, Ltd. · Dental device
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Oct 2001
Decision
77d
Days
Class 2
Risk

K012529 is an FDA 510(k) clearance for the ROK. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Southern Dental Industries, Ltd. (Bensenville, US). The FDA issued a Cleared decision on October 22, 2001 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Southern Dental Industries, Ltd. devices

FDA 510(k) Submission Details - K012529

510(k) Number K012529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date October 22, 2001
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 753
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