Voco Profluorid L
FDA 510(k) K083036 · Voco GmbH
510(k) numberK083036
Submission
- Device name
- Voco Profluorid L
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- October 14, 2008
- Decision date
- January 12, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K231817 | AlignerFlow LCDYH · Traditional | 12/01/2023SE |
| K231591 | V-Print c&b tempPOW · Traditional | 07/31/2023SE |
| K230877 | Admira Fusion 5EBF · Traditional | 07/13/2023SE |
| K220236 | V-Print dentbaseEBI · Traditional | 09/21/2022SE |
| K220640 | Bifix Hybrid Abutment CementEMA · Traditional | 08/23/2022SE |
Questions and answers
When was Voco Profluorid L cleared by the FDA?
Voco Profluorid L (K083036) received a 510(k) decision of Substantially Equivalent on January 12, 2009, 90 days after the submission was received.
What is the product code of K083036?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.