Cleared Traditional

K133412 - S200, S300 (FDA 510(k) Clearance)

Class I Dental device.

K133412 · Cefla S.C. · Dental device
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Jan 2015
Decision
427d
Days
Class 1
Risk

K133412 is an FDA 510(k) clearance for the S200, S300. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on January 8, 2015 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Cefla S.C. devices

Submission Details

510(k) Number K133412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2013
Decision Date January 08, 2015
Days to Decision 427 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
300d slower than avg
Panel avg: 127d · This submission: 427d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.

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