Home / 510(k) Clearances / K983786

510(k) K983786

STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION by Sterngold/Implamed — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1998
Date Received
October 27, 1998
Clearance Type
Special
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 Sterngold/Implamed

  • K984341 — STERNVANTAGE VARNISH LC, MODEL 221001 (January 8, 1999)
  • K984340 — STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 (January 8, 1999)
  • K982692 — STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC (October 22, 1998)
  • K982895 — STERNOMEGA COMPOMER CEMENT (October 9, 1998)
  • K981516 — STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMP (May 11, 1998)
  • K962326 — STERNGOLD BIO-5 (1127210) (July 24, 1996)
  • K962325 — QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) (July 24, 1996)
  • K962324 — STERNGOLD U-CPF METAL ALLOY (1067800) (July 24, 1996)
  • K962304 — STERNGOLD BIO-4 (July 23, 1996)
  • K962302 — PEGASUS DENTAL ALLOY (July 18, 1996)

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)