Cleared Traditional

APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 (K033198) - FDA 510(k) Clearance

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

K033198 · Apoza Enterprise Co., Ltd. · Dental device
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Apr 2004
Decision
211d
Days
Class 2
Risk

K033198 is an FDA 510(k) clearance for the APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Apoza Enterprise Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on April 30, 2004 after a review of 211 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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. Standard predicate reliance. 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 Apoza Enterprise Co., Ltd. devices

Submission Details

510(k) Number K033198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2003
Decision Date April 30, 2004
Days to Decision 211 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
84d slower than avg
Panel avg: 127d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

All 194
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