Recall Z-0019-2020— Paltop Advanced Dental Solutions Ltd

Name: FDA recall Z-0019-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-30

Class II · Terminated

Class II FDA medical device recall by Paltop Advanced Dental Solutions Ltd, initiated 2019-05-30, terminated 2020-06-09. It names one FDA 510(k) clearance: K112795. Product: Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P. Reason: 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..

Recalling firm: Paltop Advanced Dental Solutions Ltd
Classification: Class II
Status: Terminated
Initiated: 2019-05-30
Terminated: 2020-06-09
Firm location: Caesarea, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K112795 — PALTOP DENTAL IMPLANT SYSTEMPaltop Advanced Dental Solutions, Ltd.·cleared 2012-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.