Nova Cordless Curing Light

FDA 510(k) K000393 · Nova/Da Vinci Systems, Inc.

Substantially Equivalent

510(k) numberK000393

Submission

Device name
Nova Cordless Curing Light
Applicant
Nova/Da Vinci Systems, Inc.
San Diego, CA, US
Received
February 7, 2000
Decision date
March 27, 2000
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

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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

Questions and answers

When was Nova Cordless Curing Light cleared by the FDA?

Nova Cordless Curing Light (K000393) received a 510(k) decision of Substantially Equivalent on March 27, 2000, 49 days after the submission was received.

What is the product code of K000393?

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