Cleared Traditional

MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 (K042434) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042434 · NOUVAG AG · Dental device
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Nov 2004
Decision
56d
Days
Class 2
Risk

K042434 is an FDA 510(k) clearance for the MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by NOUVAG AG (Gebenstorf, CH). The FDA issued a Cleared decision on November 3, 2004 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 NOUVAG AG devices

Submission Details

510(k) Number K042434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2004
Decision Date November 03, 2004
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 - DZI Drill, Bone, Powered

All 47
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