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510(k) K021367

STERNGOLD 66, MODEL #1180230 by Sterngold — Product Code EJS

K021367 is an FDA 510(k) premarket notification submitted by Sterngold for the device "STERNGOLD 66, MODEL #1180230". The FDA issued a decision of Substantially Equivalent on May 16, 2002. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Sterngold has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2002
Date Received
April 30, 2002
Clearance Type
Abbreviated
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

  • K092434 — STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM (November 10, 2009)
  • K041271 — STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM (October 28, 2004)
  • K023580 — STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM (January 17, 2003)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K021741 — CRITERTION, MODEL #1067511 (June 26, 2002)
  • K021045 — ERA IMPLANT (June 26, 2002)
  • K020949 — APOLLO, MODEL 1124525 (April 4, 2002)
  • K020391 — STERN MICRO ERA ATTACHMENT SYSTEM (March 8, 2002)
  • K003007 — GALAXY (November 17, 2000)
  • K991436 — STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND I (May 7, 1999)

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)
  • 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)
  • K014082 — D.SIGN 53, MODEL NA1012204 (January 30, 2002)

FDA data resources