RegWardenFDA facility compliance records
Company

Paltop Advanced Dental Solutions Inc.

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

Recalls by year

FDA actions on record by year2019: 2 recalls; 2021: 1 recalls201720182201920201202120222023202420252026
  • Recalls (3)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Paltop Advanced Dental Solutions Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10043196-paltop-advanced-dental-solutions-inc/

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