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510(k) K900809

LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS by Lee Pharmaceuticals — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1990
Date Received
February 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
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)
  • 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)
  • K844133 — CLEANSE N BOND I (January 4, 1985)
  • K844134 — CLEANSE N BOND II (January 4, 1985)
  • K843363 — RESTODENT VL (October 25, 1984)

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  • K150702 — Exceed Tx (March 24, 2016)
  • K140807 — COMPOSITE ORTHODONTIC BRACKETS (November 12, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)