APOZA LED CURING LIGHT - Top 3W

510(k) Number

K070373 ↗

FDA Product Code

EBZ

Models / Variants

E-Morlit

D-2000

Top 3W

Top 5W

Device Class

Class II

Regulation

21 CFR Part 872.6070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Apoza

  Class IIa

  CE/MDD

• LED Turbo-Pen

  Class II

  FDA 510(k) K041303 Active Cleared 18 Jun 2004

• LED Turbo

  Class II

  FDA 510(k) K040618 Active Cleared 25 Mar 2004

• LA500 Blue Light

  Class II

  FDA 510(k) K033201 Active Cleared 2 Dec 2003

• Apoza Ultrasonic Scaler and Edodontics Unit, Selector U2

  Class II

  FDA 510(k) K033198 Active Cleared 30 Apr 2004

• BT Cool Easy

  Class I

  CE/MDR

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