Cleared Traditional

K935443 - ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS

K935443 is an FDA 510(k) clearance for ADD LINE DEVICES(PARTS) ELECTRIC HANDPI..., manufactured by Osada Electric Co., Ltd.. The device is a Class 2 Dental device with product code DZH cleared through the Traditional 510(k) pathway after a 312-day FDA review.

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

FDA 510(k) Submission Details - K935443

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.

DZH Device Classification - Class 2, Special Controls

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.