Cleared Traditional

BLUEPHASE 20I

K091020 · Ivoclar Vivadent, Inc. · Dental
Jun 2009
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K091020 is an FDA 510(k) clearance for the BLUEPHASE 20I, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on June 12, 2009, 64 days after receiving the submission on April 9, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K091020 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2009
Decision Date June 12, 2009
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

Similar Devices — EBZ Activator, Ultraviolet, For Polymerization

All 212
Demi Pro
K253461 · Meta Systems Co., Ltd. · Oct 2025
Bluemoon
K242386 · Genoss Co., Ltd. · May 2025
LED Curing Lights (DB686 HALO)
K243921 · Foshan Coxo Medical Instrument Co., Ltd. · Apr 2025
LED Curing Light (C01-X, C02-X)
K250009 · Premium Plus (Dongguan) Limited · Apr 2025
LOOP? LED Curing Light System (CLK01)
K241238 · Garrison Dental Solutions, LLC · Aug 2024
Curing Light, Model: MaxCure 9
K223414 · Guilin Refine Medical Instrument Co., Ltd. · Nov 2023