Curing Light Cover

FDA 510(k) K884222 · Steri-Shield Products, Inc.

Substantially Equivalent

510(k) numberK884222

Submission

Device name
Curing Light Cover
Applicant
Steri-Shield Products, Inc.
Allentown, PA, US
Received
October 6, 1988
Decision date
March 17, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K884223Dental Lamp Handle CoverEAZ · Traditional 03/17/1989SE
K884221Ultrasonic Scaler CoverELC · Traditional 03/17/1989SE
K884220Air Water Syringe Tip ShieldEFS · Traditional 03/17/1989SE
K884219Bracket Table Arm CoverEIA · Traditional 03/17/1989SE

Questions and answers

When was Curing Light Cover cleared by the FDA?

Curing Light Cover (K884222) received a 510(k) decision of Substantially Equivalent on March 17, 1989, 162 days after the submission was received.

What is the product code of K884222?

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