Cleared Traditional

K133178 - LUXATOR LX HANDPIECE

K133178 is an FDA 510(k) clearance for LUXATOR LX HANDPIECE, manufactured by Directa AB. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 768-day FDA review.

K133178 · Directa AB · Dental device
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Nov 2015
Decision
768d
Days
Class 1
Risk

K133178 is an FDA 510(k) clearance for the LUXATOR LX HANDPIECE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Directa AB (Upplands Vasby, SE). The FDA issued a Cleared decision on November 24, 2015 after a review of 768 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Directa AB devices

FDA 510(k) Submission Details - K133178

510(k) Number K133178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date November 24, 2015
Days to Decision 768 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
641d slower than avg
Panel avg: 127d · This submission: 768d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 28
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