MAZIC Duro
FDA 510(k) K163346 · Vericom Co., Ltd.
510(k) numberK163346
Submission
- Device name
- MAZIC Duro
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- November 29, 2016
- Decision date
- March 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K203672 | MAZIC Claro CAD and MAZIC Claro PressEIH · Traditional | 07/01/2021SE |
| K193260 | U-Cem Premium & MAZIC CemEMA · Traditional | 08/21/2020SE |
| K170950 | Well-Root STKIF · Traditional | 12/20/2017SE |
| K160377 | V-varnish PremiumLBH · Traditional | 12/02/2016SE |
| K152615 | Vonflex SELW · Traditional | 11/03/2016SE |
| K152518 | Vonflex S PuttyELW · Traditional | 11/30/2015SE |
| K140966 | Vonflex S BiteELW · Traditional | 08/15/2014SE |
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Questions and answers
When was MAZIC Duro cleared by the FDA?
MAZIC Duro (K163346) received a 510(k) decision of Substantially Equivalent on March 17, 2017, 108 days after the submission was received.
What is the product code of K163346?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.