Cleared Traditional

K033198 - APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2

K033198 is an FDA 510(k) clearance for APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, manufactured by Apoza Enterprise Co., Ltd.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K033198 · Apoza Enterprise Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K033198

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 128d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

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 176
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K033198.
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K042056 · J. Morita USA, Inc. · Sep 2004
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K031421 · Nakanishi, Inc. · Mar 2004
SP NEWTRON MODULE
K033764 · Satelec · Mar 2004
K033198 · APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
Download PDF FDA Summary Apoza Enterprise Co.,…