Cleared Traditional

K032099 - SWISS MASTER LIGHT

K032099 is an FDA 510(k) clearance for SWISS MASTER LIGHT, manufactured by (Ems Sa) Electro Medical Systems. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K032099 · (Ems Sa) Electro Medical Systems · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
111d
Days
Class 2
Risk

K032099 is an FDA 510(k) clearance for the SWISS MASTER LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by (Ems Sa) Electro Medical Systems (North Attleboro, US). The FDA issued a Cleared decision on October 27, 2003 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 - K032099

510(k) Number K032099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2003
Decision Date October 27, 2003
Days to Decision 111 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
17d faster than avg
Panel avg: 128d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 202
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K032099.
PLASMACURE BXE
K033795 · Eele Laboratories, LLC · Dec 2003
BLUEPHASE
K033520 · Ivoclar Vivadent, Inc. · Dec 2003
LA500 BLUE LIGHT
K033201 · Apoza Enterprise Co., Ltd. · Dec 2003
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
K032465 · Satelec · Oct 2003
SLED CURING LIGHT SYSTEM
K031615 · Dentsply International · Jul 2003
CONTEC LIGHT
K030641 · Dentaurum · Jun 2003
K032099 · SWISS MASTER LIGHT
Download PDF FDA Summary (Ems Sa) Electro Medi…