Deep Blue

FDA 510(k) K071722 · E.M.S Electro Medical Systems S.A

Substantially Equivalent

510(k) numberK071722

Submission

Device name
Deep Blue
Applicant
E.M.S Electro Medical Systems S.A
North Attleboro, MA, US
Received
June 22, 2007
Decision date
August 10, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBZ – Activator, Ultraviolet, For Polymerization
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6070
Specialty
Dental

Other 510(k)s with product code EBZ

510(k)DeviceApplicantDecision
K253131Curing Light (M-Cure 6)EBZ · Traditional Guangzhou Rebornendo Medical Instrument Co., Ltd.06/18/2026SE
K253461Demi ProEBZ · Traditional Meta Systems Co., Ltd.10/14/2025SE
K242386BluemoonEBZ · Traditional Genoss Co., Ltd.05/05/2025SE
K243921LED Curing Lights (DB686 HALO)EBZ · Traditional Foshan Coxo Medical Instrument Co., Ltd.04/11/2025SE
K250009LED Curing Light (C01-X, C02-X)EBZ · Traditional Premium Plus (Dongguan) Limited04/10/2025SE
K241238LOOP™ LED Curing Light System (CLK01)EBZ · Traditional Garrison Dental Solutions, LLC08/01/2024SE
K223414Curing Light, Model: MaxCure 9EBZ · Traditional Guilin Refine Medical Instrument Co., Ltd.11/15/2023SE
K233518BASE290 LED Curing LightEBZ · Traditional Handpiece Headquarters11/02/2023SE
K223507CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)EBZ · Traditional Good Doctors Co., Ltd.08/04/2023SE
K223142Coltolux Comfort LED Curing LightEBZ · Traditional Dent4you AG12/22/2022SE

More from Dent4you AG

510(k)DeviceDecision
K253254GBT Machine Airflow Prophylaxis MasterELC · Traditional 01/28/2026SE
K243279DOLORCLAST Focused Shock WavesPZL · Traditional 08/13/2025SE
K230893Swiss LthoClast TrilogyFEO · Traditional 10/23/2023SE
K220538DolorClast RadialISA · Traditional 07/11/2022SE
K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneELC · Traditional 10/20/2019SE
K191079Piezon Built-in Kit, Piezon Built-in Kit LEDELC · Traditional 08/16/2019SE
K191124Swiss LithoClast TrilogyFFK · Special 05/29/2019SE
K182490Swiss LithoClast TrilogyFEO · Special 10/09/2018SE
K181997Swiss LithoClast TrilogyFEO · Special 08/30/2018SE
K181364Swiss LithoClast TrilogyFEO · Special 06/20/2018SE

Questions and answers

When was Deep Blue cleared by the FDA?

Deep Blue (K071722) received a 510(k) decision of Substantially Equivalent on August 10, 2007, 49 days after the submission was received.

What is the product code of K071722?

The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.