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510(k) K822951

SPHEREX E.C.T. by Jeneric Ind. — Product Code EJJ

K822951 is an FDA 510(k) premarket notification submitted by Jeneric Ind. for the device "SPHEREX E.C.T.". The FDA issued a decision of Substantially Equivalent on October 26, 1982. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Jeneric Ind. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1982
Date Received
October 4, 1982
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 Jeneric Ind.

  • K862822 — REXILLIUM N. B. F. (September 2, 1986)
  • K862926 — SURGICAL VITEX (August 29, 1986)
  • K854878 — H40 BASE METAL ALLOY (January 30, 1986)
  • K844123 — RX CBY (January 9, 1985)
  • K844122 — RX CBG (January 9, 1985)
  • K840561 — RX ELAN (May 1, 1984)
  • K840563 — RX C & B 20 (May 1, 1984)
  • K840562 — REX V (April 13, 1984)
  • K834560 — VITEX P.D.A (February 27, 1984)
  • K833774 — NATURELLE II & LITE II-N72-N74-L (January 24, 1984)

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)
  • K031658 — BENCO SPHERICAL (July 29, 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)
  • K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (October 31, 2000)
  • K002811 — ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (October 31, 2000)

FDA data resources