Home / 510(k) Clearances / K933532

510(k) K933532

SELF TAPPING DENTAL IMPLANT SYSTEM by Implant Support Systems, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1994
Date Received
July 21, 1993
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 Implant Support Systems, Inc.

  • K924589 — RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (June 22, 1994)
  • K925312 — HAND INSTRUMENT CALCULUS REMOVAL (May 23, 1994)
  • K925313 — TITANIUM COC ABUTMENT HEADS FOR IMZ (July 30, 1993)
  • K925349 — ONE SYSTEM TAPERED TITANIUM ABUTMENTS (July 27, 1993)
  • K924190 — ISS O-RING ATTACHMENT (May 27, 1993)
  • K921764 — DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS (November 3, 1992)
  • K904605 — TITANIUM COC ABUTMENT HEADS FOR IMZ (January 29, 1991)
  • K895986 — PRECISION DENTAL ATTACHMENTS (October 18, 1989)
  • K892239 — DENTAL HAND INSTRUMENTS (May 18, 1989)

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)