510(k) K130672
K130672 is an FDA 510(k) premarket notification submitted by Pac-Dent International, Inc. for the device "OPTIFLOW II FLOWABLE COMPOSITE, LC". The FDA issued a decision of Substantially Equivalent on August 13, 2013. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Pac-Dent International, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2013
- Date Received
- March 12, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type