Home / 510(k) Clearances / K210117

510(k) K210117

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2021
Date Received
January 19, 2021
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.

  • K243983 — Paltop Dental Implant System (September 29, 2025)
  • K232740 — Paltop Short Implants (May 22, 2024)
  • K220200 — Paltop Conical Implant System (May 25, 2022)
  • 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)

Other clearances for product code DZE

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K252286 — BIORES Dental Implant System (February 2, 2026)
  • K252585 — ZENEX Implant System_R-System (January 8, 2026)
  • K250476 — NizPlant Dental Implant System (December 23, 2025)
  • K252145 — GEN5™ and GEN5+™ 3.3mmD Dental Implants (December 23, 2025)
  • K251605 — DIMPLO Implant System (December 22, 2025)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System (November 7, 2025)