Paltop Advanced Dental Solutions Ltd
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0013-2022 | Class II | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral s | July 26, 2021 |
| Z-0017-2022 | Class II | Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral | July 26, 2021 |
| Z-0018-2022 | Class II | Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral | July 26, 2021 |
| Z-0015-2022 | Class II | Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral | July 26, 2021 |
| Z-0016-2022 | Class II | Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral | July 26, 2021 |
| Z-0014-2022 | Class II | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral s | July 26, 2021 |
| Z-0836-2020 | Class II | Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020 | November 18, 2019 |
| Z-0019-2020 | Class II | Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P | May 30, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243983 | Paltop Dental Implant System | September 29, 2025 |
| K232740 | Paltop Short Implants | May 22, 2024 |
| K220200 | Paltop Conical Implant System | May 25, 2022 |
| K210117 | Paltop Narrow Implant | November 30, 2021 |
| K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | August 27, 2013 |
| K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | August 22, 2013 |
| K112795 | PALTOP DENTAL IMPLANT SYSTEM | April 20, 2012 |