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510(k) K003387

AUROFILM NP by Metalor Dental USA Corp. — Product Code EJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2001
Date Received
October 31, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

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  • K993507 — V-SUPRAGOLD, ALLOY NO. 5024 (December 6, 1999)
  • K993474 — DELTAPAL, ALLOY NO. 5161 (December 2, 1999)
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  • K970044 — AUROFLUID 22 (March 5, 1997)

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