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510(k) K780966

LEE-ALLOY DISPOSABLE CAPSULES by Lee Pharmaceuticals — Product Code DZS

K780966 is an FDA 510(k) premarket notification submitted by Lee Pharmaceuticals for the device "LEE-ALLOY DISPOSABLE CAPSULES". The FDA issued a decision of Substantially Equivalent on August 21, 1978. The device falls under product code DZS (Capsule, Dental, Amalgam), a Class I device regulated under 21 CFR 872.3110. 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
Capsule, Dental, Amalgam
Device Class
Class I
Regulation Number
872.3110
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 DZS

  • K822610 — PRECAPSULED DENTAL AMALGAM (September 14, 1982)
  • K802967 — DISPERSALLOY-DISPERSED PHASE ALLOY SELF- (December 30, 1980)
  • K781243 — MERCURY DISP. CAPSULE (September 20, 1978)

FDA data resources