Cleared Traditional

ODONTOSURGE 3 (K001560) - FDA 510(k) Clearance

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

K001560 · Odonto-Wave · Dental device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
97d
Days
Class 2
Risk

K001560 is an FDA 510(k) clearance for the ODONTOSURGE 3. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Odonto-Wave (Fort Collins, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - 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.

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Submission Details

510(k) Number K001560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2000
Decision Date August 24, 2000
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
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.