Tutu 7, Model IV-T22

FDA 510(k) K062735 · Invisible Technology Co., Ltd.

Substantially Equivalent

510(k) numberK062735

Submission

Device name
Tutu 7, Model IV-T22
Applicant
Invisible Technology Co., Ltd.
Carmel, IN, US
Received
September 13, 2006
Decision date
October 27, 2006
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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Questions and answers

When was Tutu 7, Model IV-T22 cleared by the FDA?

Tutu 7, Model IV-T22 (K062735) received a 510(k) decision of Substantially Equivalent on October 27, 2006, 44 days after the submission was received.

What is the product code of K062735?

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