Sylphar Remesense Sensitivity Relief Strips
FDA 510(k) K132426 · Sylphar N.V.
510(k) numberK132426
Submission
- Device name
- Sylphar Remesense Sensitivity Relief Strips
- Applicant
- Sylphar N.V.
Rome, IT - Received
- August 5, 2013
- Decision date
- February 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K122708 | Remesense for Sensitive TeethLBH · Traditional | 01/14/2013SE |
Questions and answers
When was Sylphar Remesense Sensitivity Relief Strips cleared by the FDA?
Sylphar Remesense Sensitivity Relief Strips (K132426) received a 510(k) decision of Substantially Equivalent on February 14, 2014, 193 days after the submission was received.
What is the product code of K132426?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.