510(k) K102836
K102836 is an FDA 510(k) premarket notification submitted by Dmp, Ltd. for the device "BONASIL A+ IMPRESSION MATERIALS". The FDA issued a decision of Substantially Equivalent on January 13, 2011. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Dmp, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2011
- Date Received
- September 29, 2010
- 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