DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S
FDA 510(k) K120048 · Drfp , Ltd.
510(k) numberK120048
Submission
- Device name
- DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S
- Applicant
- Drfp , Ltd.
Amsterdam, GB - Received
- January 6, 2012
- Decision date
- June 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Voco GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SKIF · Traditional | 10/22/2010SE |
Questions and answers
When was DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S cleared by the FDA?
DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S (K120048) received a 510(k) decision of Substantially Equivalent on June 20, 2012, 166 days after the submission was received.
What is the product code of K120048?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.