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510(k) K053114

SILVERFIL by Dunia Perwira Manufacturing Sdn. Bhd. — Product Code EJJ

K053114 is an FDA 510(k) premarket notification submitted by Dunia Perwira Manufacturing Sdn. Bhd. for the device "SILVERFIL". The FDA issued a decision of Substantially Equivalent on November 15, 2005. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2005
Date Received
November 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Alloy, Amalgam
Device Class
Class II
Regulation Number
872.3070
Review Panel
DE
Submission Type

Other clearances for product code EJJ

  • K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (May 2, 2005)
  • K033434 — BESTALOY (November 12, 2003)
  • K032152 — BENCO ADMIX (August 6, 2003)
  • K031658 — BENCO SPHERICAL (July 29, 2003)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (October 31, 2000)
  • K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (October 31, 2000)
  • K002811 — ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (October 31, 2000)
  • K991481 — PARAGON (August 11, 1999)

FDA data resources