Facility

PALTOP ADVANCED DENTAL SOLUTIONS LTD

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009161350
Establishment type	Manufacture Medical Device
Location	Hashita 5, Industrial Park Caesarea Central, IL 30889
Registration status	Active · expires 2026
Parent company	Paltop Advanced Dental Solutions Inc. (owner-operator 10043196)
Brand names	Paltop Short Implants

Activity by year

Recalls (3)

Devices registered here (2)

Implant, Endosseous, Root-Form
Product code DZE (opens in a new tab) · Class II · Dental · 21 CFR 872.3640
Abutment, Implant, Dental, Endosseous
Product code NHA (opens in a new tab) · Class II · Dental · 21 CFR 872.3630

Recalls & enforcement

Class IITerminated2021-07-26
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 between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Class IITerminated2019-11-18
Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.
Class IITerminated2019-05-30
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.

All facilities operated by Paltop Advanced Dental Solutions Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PALTOP ADVANCED DENTAL SOLUTIONS LTD (FEI 3009161350) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009161350-paltop-advanced-dental-solutions-ltd/

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