Home / 510(k) Clearances / K971196

510(k) K971196

ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM by Innova Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1997
Date Received
March 31, 1997
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 Innova Corp.

  • K040714 — HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT (April 9, 2004)
  • K984117 — INNOVA TELESCOPIC DISTRACTOR (February 10, 1999)
  • K952434 — ENDOPORE DENTAL IMPLANT ABUTMENTS (July 19, 1995)
  • K926354 — ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (February 13, 1995)
  • K915361 — THE BODY BUGGY (December 20, 1991)

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)