HyperFil-LV
FDA 510(k) K182296 · Parkell, Inc.
510(k) numberK182296
Submission
- Device name
- HyperFil-LV
- Applicant
- Parkell, Inc.
Edgewood, NY, US - Received
- August 24, 2018
- Decision date
- December 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
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Questions and answers
When was HyperFil-LV cleared by the FDA?
HyperFil-LV (K182296) received a 510(k) decision of Substantially Equivalent on December 14, 2018, 112 days after the submission was received.
What is the product code of K182296?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.