510(k) K111189
K111189 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "SYNTEC DENTAL IMPLANT". The FDA issued a decision of Substantially Equivalent on Dec 20, 2012. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Syntec Scientific Corp. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2012
- Date Received
- Apr 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)