Cleared Traditional

K192412 - SD500 Elite LubeFree High Speed Handpiece

K192412 is the FDA 510(k) clearance for SD500 Elite LubeFree High Speed Handpiece by Dentalez, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K192412 · Dentalez, Inc. · Dental device
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Jan 2020
Decision
124d
Days
Class 1
Risk

K192412 is an FDA 510(k) clearance for the SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed .... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentalez, Inc. (Lancaster, US). The FDA issued a Cleared decision on January 6, 2020 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Dentalez, Inc. devices

Submission Details

510(k) Number K192412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date January 06, 2020
Days to Decision 124 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
3d faster than avg
Panel avg: 127d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 66
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