TP Orthodontics, Inc.
FDA Regulatory Profile
TP Orthodontics, Inc. appears in FDA public data with 13 recalls, 5 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1787-2018, Class II) was initiated on May 1, 2018. Its most recent 510(k) clearance was granted on October 14, 2022.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1787-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclu | May 1, 2018 |
| Z-1793-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclu | May 1, 2018 |
| Z-1792-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclus | May 1, 2018 |
| Z-1784-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclus | May 1, 2018 |
| Z-1795-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclu | May 1, 2018 |
| Z-1789-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclu | May 1, 2018 |
| Z-1791-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclus | May 1, 2018 |
| Z-1790-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclu | May 1, 2018 |
| Z-1783-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclus | May 1, 2018 |
| Z-1788-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclu | May 1, 2018 |
| Z-1794-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclu | May 1, 2018 |
| Z-1785-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclus | May 1, 2018 |
| Z-1786-2018 | Class II | Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclus | May 1, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Et | October 14, 2022 |
| K193385 | TP Orthodontics Clear Aligner System | November 12, 2020 |
| K111234 | CLICK-IT | May 13, 2011 |
| K952643 | RIGHT-ON ADHESIVE BOUDING SYSTEM | July 11, 1995 |
| K950992 | CERAMAFLEX BRACKET SYSTEM | May 3, 1995 |