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510(k) K973288

STABILOR HN by Degussa Corp. — Product Code EJS

K973288 is an FDA 510(k) premarket notification submitted by Degussa Corp. for the device "STABILOR HN". The FDA issued a decision of Substantially Equivalent on November 19, 1997. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Degussa Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1997
Date Received
September 2, 1997
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 Degussa Corp.

  • K972910 — PORS ON LITE (October 14, 1997)
  • K960256 — DEGUDENT LS (February 21, 1996)
  • K960226 — DG 88 (February 14, 1996)
  • K960104 — BIOCCLUS 4 (February 6, 1996)
  • K955465 — DEGUPRINT (December 28, 1995)
  • K955118 — DEGUBOND X-LITE PLUS (December 11, 1995)
  • K955027 — DEGUBOND X-LITE (December 1, 1995)
  • K953344 — DEGUBOND ULTRA (August 25, 1995)
  • K951789 — PALLIAG NF IV (June 14, 1995)
  • K951791 — DEPALOR (June 12, 1995)

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