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510(k) K031658

BENCO SPHERICAL by Southern Dental Industries, Inc. — Product Code EJJ

K031658 is an FDA 510(k) premarket notification submitted by Southern Dental Industries, Inc. for the device "BENCO SPHERICAL". The FDA issued a decision of Substantially Equivalent on July 29, 2003. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Southern Dental Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2003
Date Received
May 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Southern Dental Industries, Inc.

  • K062065 — RIVA LUTING PLUS (November 15, 2006)
  • K062064 — RIVA BOND LC (November 9, 2006)
  • K051008 — SET (June 15, 2005)
  • K050871 — RIVA PROTECT (June 10, 2005)
  • K050870 — RIVA LIGHT CURE (June 3, 2005)
  • K050331 — ADHESIVE 1 (March 24, 2005)
  • K042452 — RIVA SILVER (December 7, 2004)
  • K040393 — RIVA LUTING (April 30, 2004)
  • K032152 — BENCO ADMIX (August 6, 2003)
  • K030568 — RADII (April 24, 2003)

Other clearances for product code EJJ

  • K053114 — SILVERFIL (November 15, 2005)
  • K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (May 2, 2005)
  • K033434 — BESTALOY (November 12, 2003)
  • K032152 — BENCO ADMIX (August 6, 2003)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • 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)
  • K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (October 31, 2000)
  • K991481 — PARAGON (August 11, 1999)

FDA data resources