Z-0019-2020Class II

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

Name: Z-0019-2020 Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Creator: Paltop Advanced Dental Solutions Ltd
Published: 2019-05-30
License: https://open.fda.gov/license/

Paltop Advanced Dental Solutions Ltd / initiated 2019-05-30 / Terminated

FDA source

Paltop Advanced Dental Solutions Ltd began a recall of Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P on 2019-05-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0019-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-30
Posted: 2019-10-01
Terminated: 2020-06-09
Recalling firm: Paltop Advanced Dental Solutions Ltd
Product: Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Product code: DZE Implant, Endosseous, Root-Form
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 root cause: 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
Distribution: AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA
Product codes and lots: Lot Number: W0-008254 UDI: 729010869611020-70024P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0019-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0019-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01

Product code DZE

K112795Class IIPaltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. / cleared 2012-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)