LED Turbo
FDA 510(k) K040618 · Apoza Enterprise Co., Ltd.
510(k) numberK040618
Submission
- Device name
- LED Turbo
- Applicant
- Apoza Enterprise Co., Ltd.
Taipei Hsien, TW - Received
- March 9, 2004
- Decision date
- March 25, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K070373 | Apoza LED Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5WEBZ · Special | 03/02/2007SE |
| K041303 | LED Turbo-PenEBZ · Traditional | 06/18/2004SE |
| K033198 | Apoza Ultrasonic Scaler and Edodontics Unit, Selector U2ELC · Traditional | 04/30/2004SE |
| K033201 | LA500 Blue LightEBZ · Traditional | 12/02/2003SE |
Questions and answers
When was LED Turbo cleared by the FDA?
LED Turbo (K040618) received a 510(k) decision of Substantially Equivalent on March 25, 2004, 16 days after the submission was received.
What is the product code of K040618?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.