Clearfil Majesty Posterior PLT
FDA 510(k) K092281 · Kuraray Medical, Inc.
510(k) numberK092281
Submission
- Device name
- Clearfil Majesty Posterior PLT
- Applicant
- Kuraray Medical, Inc.
New York, NY, US - Received
- July 29, 2009
- Decision date
- October 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K111975 | Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKLE · Traditional | 10/14/2011SE |
| K100328 | Clearfil Majety PosteriorEBF · Special | 03/05/2010SE |
| K081583 | Clearfil SA CementEMA · Traditional | 07/28/2008SE |
| K071169 | Clearfil Majesty Posterior PLTEBF · Traditional | 06/20/2007SE |
| K070325 | Clearfil Majesty Esthetic PLTEBF · Traditional | 03/21/2007SE |
| K062409 | K-Etchant GelEBF · Traditional | 11/08/2006SE |
| K061906 | Clearfil Ceramic PrimerEBF · Traditional | 09/28/2006SE |
| K062382 | Clearfil DC BondKLE · Traditional | 09/27/2006SE |
Questions and answers
When was Clearfil Majesty Posterior PLT cleared by the FDA?
Clearfil Majesty Posterior PLT (K092281) received a 510(k) decision of Substantially Equivalent on October 27, 2009, 90 days after the submission was received.
What is the product code of K092281?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.