VITA Akzent LC
FDA 510(k) K211854 · Vita Zahnfabrik GmbH H Rauter & CO
510(k) numberK211854
Submission
- Device name
- VITA Akzent LC
- Applicant
- Vita Zahnfabrik GmbH H Rauter & CO
Bad Sackingen, DE - Received
- June 16, 2021
- Decision date
- November 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K162408 | Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional | Dreve Dentamid GmbH | 04/05/2018SE |
| K163568 | Shofu Resin GlazeEBD · Traditional | Shofu Dental Corporation | 08/16/2017SE |
| K133836 | Optiglaze ColorEBD · Traditional | GC America, Inc. | 03/06/2014SE |
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| K093019 | Enamelite Acryseal Spray SealantEBD · Traditional | Enamelite, LLC | 12/22/2009SE |
| K082285 | Easy GlazeEBD · Traditional | Voco GmbH | 10/24/2008SE |
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Questions and answers
When was VITA Akzent LC cleared by the FDA?
VITA Akzent LC (K211854) received a 510(k) decision of Substantially Equivalent on November 22, 2021, 159 days after the submission was received.
What is the product code of K211854?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.