Coolblu Curing Light

FDA 510(k) K002925 · Dental Systems.Com, Inc.

Substantially Equivalent

510(k) numberK002925

Submission

Device name
Coolblu Curing Light
Applicant
Dental Systems.Com, Inc.
Heathrow, FL, US
Received
September 19, 2000
Decision date
December 20, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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More from Dent4you AG

510(k)DeviceDecision
K020171COOLBLU2 Dental Resin Curing DeviceEBZ · Special 01/29/2002SE

Questions and answers

When was Coolblu Curing Light cleared by the FDA?

Coolblu Curing Light (K002925) received a 510(k) decision of Substantially Equivalent on December 20, 2000, 92 days after the submission was received.

What is the product code of K002925?

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