Cervitec F
FDA 510(k) K191453 · Ivoclar Vivadent, AG
510(k) numberK191453
Submission
- Device name
- Cervitec F
- Applicant
- Ivoclar Vivadent, AG
Schaan, LI - Received
- May 31, 2019
- Decision date
- February 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
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| K193193 | Telio CAD Abutment Solutions- extra systemsNHA · Abbreviated | 11/16/2020SE |
| K191448 | Barrier SleevesPEM · Traditional | 10/08/2019SE |
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Questions and answers
When was Cervitec F cleared by the FDA?
Cervitec F (K191453) received a 510(k) decision of Substantially Equivalent on February 11, 2020, 256 days after the submission was received.
What is the product code of K191453?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.