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510(k) K962304

STERNGOLD BIO-4 by Sterngold/Implamed — Product Code EJS

K962304 is an FDA 510(k) premarket notification submitted by Sterngold/Implamed for the device "STERNGOLD BIO-4". The FDA issued a decision of Substantially Equivalent on July 23, 1996. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Sterngold/Implamed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1996
Date Received
June 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
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)
  • K983786 — STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INS (November 13, 1998)
  • 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)
  • K962302 — PEGASUS DENTAL ALLOY (July 18, 1996)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources