WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K243983

510(k) cleared

Paltop Dental Implant System

Paltop Advanced Dental Solutions, Ltd. · Sep 29, 2025 · K243983

FDA cleared the Paltop Dental Implant System from Paltop Advanced Dental Solutions, Ltd. on Sep 29, 2025 under K243983, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 23, 2024. The decision came 280 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Paltop Advanced Dental Solutions, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243983?

K243983 is the FDA 510(k) for Paltop Dental Implant System, submitted by Paltop Advanced Dental Solutions, Ltd.. FDA's decision date was Sep 29, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the Paltop Dental Implant System?

Paltop Advanced Dental Solutions, Ltd., based in Caesarea, is the applicant of record for K243983.

How long did the K243983 review take?

FDA received the submission on Dec 23, 2024 and issued its decision on Sep 29, 2025, 280 days later.

← All decisions in September 2025