Clearfil DC Bond
FDA 510(k) K062382 · Kuraray Medical, Inc.
510(k) numberK062382
Submission
- Device name
- Clearfil DC Bond
- Applicant
- Kuraray Medical, Inc.
New York, NY, US - Received
- August 15, 2006
- Decision date
- September 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K092281 | Clearfil Majesty Posterior PLTEBF · Traditional | 10/27/2009SE |
| 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 |
Questions and answers
When was Clearfil DC Bond cleared by the FDA?
Clearfil DC Bond (K062382) received a 510(k) decision of Substantially Equivalent on September 27, 2006, 43 days after the submission was received.
What is the product code of K062382?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.