Home / 510(k) Clearances / K810517

510(k) K810517

INSTA-BOND by Lee Pharmaceuticals — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1981
Date Received
February 25, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
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)
  • K844133 — CLEANSE N BOND I (January 4, 1985)
  • K844134 — CLEANSE N BOND II (January 4, 1985)

Other clearances for product code DYH

  • K250015 — Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree (January 3, 2025)
  • K242537 — BracePaste Fluoride Sealant (August 27, 2024)
  • K234043 — 3M™ Transbond™ Orthodontic Adhesive (December 22, 2023)
  • K231817 — AlignerFlow LC (December 1, 2023)
  • K214054 — TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive (October 14, 2022)
  • K210115 — FiteBac CC OrthoSeal (July 29, 2021)
  • K192682 — Orthocem, Ortho Bite (August 14, 2020)
  • K202276 — BracePaste Band and Build LC (August 14, 2020)
  • K193388 — GlassLok Kits, GlassLok Powder, GlassLok Liquid (April 27, 2020)
  • K183147 — BrackFix (March 1, 2019)