Cleared Traditional

K030146 - KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (FDA 510(k) Clearance)

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

K030146 · Kavo America · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
931d
Days
Class 2
Risk

K030146 is an FDA 510(k) clearance for the KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+. Classified as Laser, Dental, Soft Tissue (product code NVK), Class II - Special Controls.

Submitted by Kavo America (Lake Zurich, US). The FDA issued a Cleared decision on August 3, 2005 after a review of 931 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4810 - 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 Kavo America devices

Submission Details

510(k) Number K030146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2003
Decision Date August 03, 2005
Days to Decision 931 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
804d slower than avg
Panel avg: 127d · This submission: 931d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NVK Laser, Dental, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.
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 - NVK Laser, Dental, Soft Tissue

All 15
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