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510(k) K972683

V-DELTA 450 by Metalor Dental USA Corp. — Product Code EJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1997
Date Received
July 17, 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

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  • 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)
  • K970044 — AUROFLUID 22 (March 5, 1997)

Other clearances for product code EJS

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