Cleared Traditional

K902402 - HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE

K902402 is an FDA 510(k) clearance for HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE, manufactured by Dentalez Group. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K902402 · Dentalez Group · Dental device
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Aug 1990
Decision
90d
Days
Class 2
Risk

K902402 is an FDA 510(k) clearance for the HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on August 29, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Group devices

FDA 510(k) Submission Details - K902402

510(k) Number K902402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1990
Decision Date August 29, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 724
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K902402.
HELIOLINK TRY-IN PASTES
K903587 · Ivoclar North America, Inc. · Oct 1990
TEMPOREX
K903551 · Scientific Pharmaceuticals, Inc. · Oct 1990
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K902893 · Medical Device Inspection Co., Inc. · Sep 1990
DEGUFILL (R) M
K901868 · Degussa AG · Aug 1990
DEGUFILL (R) H
K901869 · Degussa AG · Aug 1990
DEGUFILL (TM)
K902745 · Degussa AG · Aug 1990