Chrysalis Intelligence · Sponsors · Paltop Advanced Dental Solutions, Ltd.

Paltop Advanced Dental Solutions, Ltd.

Caesarea, IL · 4 510(k) clearances · 6 recalls

Total clearances
4
2021-11-30 → 2025-09-29
Last 12 months
1
Product codes
1
Most recent
2025-09-29
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DZE Implant, Endosseous, Root-Form Class II Dental 4 2025-09-29
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
0
Most recent
2021-07-26
DateSeverityStatusRecall # ProductCodeReason
2021-07-26 Class II Terminated Z-0018-2022 Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical s… Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence …
2021-07-26 Class II Terminated Z-0017-2022 Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical … Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence …
2021-07-26 Class II Terminated Z-0016-2022 Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical s… Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence …
2021-07-26 Class II Terminated Z-0015-2022 Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical s… Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence …
2021-07-26 Class II Terminated Z-0014-2022 Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical sc… Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence …
2021-07-26 Class II Terminated Z-0013-2022 Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical sc… Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence …
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-09-29 K243983 Paltop Dental Implant System DZE Class II Dental
2024-05-22 K232740 Paltop Short Implants DZE Class II Dental
2022-05-25 K220200 Paltop Conical Implant System DZE Class II Dental
2021-11-30 K210117 Paltop Narrow Implant DZE Class II Dental