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510(k) K970044

AUROFLUID 22 by Metalor Dental USA Corp. — Product Code EJS

K970044 is an FDA 510(k) premarket notification submitted by Metalor Dental USA Corp. for the device "AUROFLUID 22". The FDA issued a decision of Substantially Equivalent on March 5, 1997. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Metalor Dental USA Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1997
Date Received
January 6, 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 Metalor Dental USA Corp.

  • K003387 — AUROFILM NP (January 9, 2001)
  • K993475 — AUROFLUID M, ALLOY NO. 5315 (December 9, 1999)
  • K993505 — V-DELTA SPECIAL, ALLOY NO. 5154 (December 8, 1999)
  • K993506 — PAGALINOR 4 , ALLOY NO. 5440 (December 8, 1999)
  • K993508 — V-SUPRA PLUS, ALLOY NO. 5025 (December 6, 1999)
  • K993507 — V-SUPRAGOLD, ALLOY NO. 5024 (December 6, 1999)
  • K993474 — DELTAPAL, ALLOY NO. 5161 (December 2, 1999)
  • K982606 — AUROFLUID CPF (October 15, 1998)
  • K973372 — AUROFILM 2000 (November 26, 1997)
  • K972683 — V-DELTA 450 (August 18, 1997)

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