510(k) K113739
K113739 is an FDA 510(k) premarket notification submitted by Materialise Dental NV for the device "SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 30, 2012. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Materialise Dental NV has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2012
- Date Received
- Dec 20, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)