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510(k) K243983

Paltop Dental Implant System by Paltop Advanced Dental Solutions, Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2025
Date Received
December 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Paltop Advanced Dental Solutions, Ltd.

  • K232740 — Paltop Short Implants (May 22, 2024)
  • K220200 — Paltop Conical Implant System (May 25, 2022)
  • K210117 — Paltop Narrow Implant (November 30, 2021)
  • K130462 — PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT (August 27, 2013)
  • K131451 — PALTOP DENTAL IMPLANT - STERILE ACCESSORIES (August 22, 2013)
  • K112795 — PALTOP DENTAL IMPLANT SYSTEM (April 20, 2012)

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