LED Turbo-Pen
FDA 510(k) K041303 · Apoza Enterprise Co., Ltd.
510(k) numberK041303
Submission
- Device name
- LED Turbo-Pen
- Applicant
- Apoza Enterprise Co., Ltd.
Taipei Hsien, TW - Received
- May 17, 2004
- Decision date
- June 18, 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 |
| K033198 | Apoza Ultrasonic Scaler and Edodontics Unit, Selector U2ELC · Traditional | 04/30/2004SE |
| K040618 | LED TurboEBZ · Traditional | 03/25/2004SE |
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Questions and answers
When was LED Turbo-Pen cleared by the FDA?
LED Turbo-Pen (K041303) received a 510(k) decision of Substantially Equivalent on June 18, 2004, 32 days after the submission was received.
What is the product code of K041303?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.