Specialty Appliance Works, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1502-2015 | Class II | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect chang | March 9, 2015 |
| Z-1504-2015 | Class II | TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used | March 9, 2015 |
| Z-1509-2015 | Class II | TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crow | March 9, 2015 |
| Z-1503-2015 | Class II | MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Applianc | March 9, 2015 |
| Z-1507-2015 | Class II | HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set | March 9, 2015 |
| Z-1506-2015 | Class II | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in | March 9, 2015 |
| Z-1505-2015 | Class II | Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScop | March 9, 2015 |
| Z-1511-2015 | Class II | TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/ | March 9, 2015 |
| Z-1510-2015 | Class II | Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Applian | March 9, 2015 |
| Z-1508-2015 | Class II | LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst Appliance | March 9, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183643 | Clear Image Aligners | January 3, 2019 |
| K083209 | ACRYLIC HERBST SPLINT APPLIANCE | January 27, 2009 |
| K071970 | CLEAR IMAGE ALIGNER | September 25, 2007 |