Southern Implants, Inc
FDA Regulatory Profile
Southern Implants, Inc appears in FDA public data with 2 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1265-2015, Class II) was initiated on January 23, 2015. Its most recent 510(k) clearance was granted on October 14, 2010.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1265-2015 | Class II | MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9 | January 23, 2015 |
| Z-0382-2014 | Class II | Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System i | September 13, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K093562 | ENDOSSEOUS DENTAL IMPLANT | October 14, 2010 |
| K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | December 22, 2008 |
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | November 16, 2007 |
| K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | June 21, 2007 |
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | May 24, 2007 |