510(k) K151150
K151150 is an FDA 510(k) premarket notification submitted by Pac-Dent International, Inc. for the device "Elements". The FDA issued a decision of Substantially Equivalent on July 28, 2015. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Pac-Dent International, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2015
- Date Received
- April 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type