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510(k) K781242

ALLOY, AMALGAM, DISP. CAPSULE by Lee Pharmaceuticals — Product Code EJJ

K781242 is an FDA 510(k) premarket notification submitted by Lee Pharmaceuticals for the device "ALLOY, AMALGAM, DISP. CAPSULE". The FDA issued a decision of Substantially Equivalent on August 21, 1978. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Lee Pharmaceuticals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1978
Date Received
June 12, 1978
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 Lee Pharmaceuticals

  • K924378 — RESTOBOND 4 (March 31, 1993)
  • K912256 — PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT (July 24, 1991)
  • K900809 — LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS (June 28, 1990)
  • K894315 — RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT (October 31, 1989)
  • K881903 — PROSTHODENT VL (July 1, 1988)
  • K873123 — LEE COMPOSITE INLAY SYSTEM (January 20, 1988)
  • K863157 — RESTODENT POSTERIOR (September 25, 1986)
  • K854882 — PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT (January 30, 1986)
  • K844134 — CLEANSE N BOND II (January 4, 1985)
  • K844133 — CLEANSE N BOND I (January 4, 1985)

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