Home / 510(k) Clearances / K071070

510(k) K071070

OLYMPUS DENTAL IMPLANT SYSTEM by Keystone Dental, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2007
Date Received
April 16, 2007
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 Keystone Dental, Inc.

  • K240966 — Prima Plus Conical Implant System (July 9, 2024)
  • K223814 — Genesis ACTIVE Implant System (May 25, 2023)
  • K221381 — KDG Abutments (August 10, 2022)
  • K201334 — Keystone Dental XL Dental Implant System (August 18, 2020)
  • K101545 — GENESIS IMPLANT SYSTEM (October 28, 2010)
  • K090397 — XPI ANGLED ABUTMENTS (June 5, 2009)
  • K071599 — EASYGUIDE (July 11, 2007)

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)