510(k) K112501
K112501 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "VENUS PEARL PLT REFILL A1". The FDA issued a decision of Substantially Equivalent on December 14, 2011. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Heraeus Kulzer, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2011
- Date Received
- August 30, 2011
- 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