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510(k) K781977

APPLICATOR, LEE IMPRESSION by Lee Pharmaceuticals — Product Code EID

K781977 is an FDA 510(k) premarket notification submitted by Lee Pharmaceuticals for the device "APPLICATOR, LEE IMPRESSION". The FDA issued a decision of Substantially Equivalent on December 20, 1978. The device falls under product code EID (Syringe, Restorative And Impression Material), a Class I device regulated under 21 CFR 872.4565. Lee Pharmaceuticals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
November 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Restorative And Impression Material
Device Class
Class I
Regulation Number
872.4565
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 EID

  • K941431 — BONE GRAFT DELIVERY SYRINGES (July 12, 1994)
  • K913974 — ACCESS IMPRESSION BARREL (February 25, 1992)
  • K873153 — CAULK'S VPS CARTRIDGE SYSTEM (September 16, 1987)
  • K871937 — IMPRESSION SYRINGE (June 5, 1987)
  • K863998 — COLTENE JET-MIXER (October 30, 1986)
  • K853282 — CENTRIX RIBBON TUBES (August 23, 1985)
  • K851386 — UNITEK DISPOSABLE IMPRESSION SYRINGE (April 29, 1985)
  • K812680 — G-C IMPRESSION SYRINGE (October 6, 1981)
  • K812277 — PRISMA-FIL COMPULES (September 8, 1981)
  • K811582 — THE PLACER (July 28, 1981)

FDA data resources