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U.S. Department of Health and Human Services

Class 2 Device Recall Paltop Advanced Plus Dental Implant

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  Class 2 Device Recall Paltop Advanced Plus Dental Implant see related information
Date Initiated by Firm May 30, 2019
Create Date October 01, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-0019-2020
Recall Event ID 83198
510(K)Number K112795  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm
Catalog Number: 20-70024P
Code Information Lot Number: W0-008254 UDI: 729010869611020-70024P
Recalling Firm/
Paltop Advanced Dental Solutions Ltd
5, Ha-Shita
Caesarea Israel
Manufacturer Reason
for Recall
Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
FDA Determined
Cause 2
Under Investigation by firm
Action Keystone Dental Customer Relations initiated notification via phone calls to each impacted end user between May 30 and June 7, 2019. A market correction Letter issued to customers on June 11 via overnight Federal Express. Customer Relations Reply Forms are being used to document the communication and product status of each end user. Any unused Implants should be returned as soon as reasonably possible.
Quantity in Commerce 167 units
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = PALTOP ADVANCED DENTAL SOLUTIONS LTD