Cleared Traditional

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS (K935443) - FDA 510(k) Clearance

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

K935443 · Osada Electric Co., Ltd. · Dental device
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Sep 1994
Decision
312d
Days
Class 2
Risk

K935443 is an FDA 510(k) clearance for the ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS. Classified as Saw, Bone, Ac-powered (product code DZH), Class II - Special Controls.

Submitted by Osada Electric Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Osada Electric Co., Ltd. devices

Submission Details

510(k) Number K935443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1993
Decision Date September 20, 1994
Days to Decision 312 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
185d slower than avg
Panel avg: 127d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZH Saw, Bone, Ac-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.