Home / 510(k) Clearances / K160782

510(k) K160782

BracePaste Adhesive by American Orthodontics — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2016
Date Received
March 22, 2016
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 American Orthodontics

  • K242537 — BracePaste Fluoride Sealant (August 27, 2024)
  • K232011 — Cleo (July 7, 2023)
  • K202276 — BracePaste Band and Build LC (August 14, 2020)
  • K181910 — BracePaste MTP Light Cure Primer (October 15, 2018)
  • K172953 — Acid Etchant (February 6, 2018)
  • K143117 — Wire Sterilization Package with Indicators (October 29, 2015)
  • K122753 — EMPOWER CLEAR (December 14, 2012)
  • K080749 — RADIANCE (August 4, 2008)
  • K925012 — PLASTIC CHAIN (September 13, 1993)
  • K922984 — ORTHODONTIC BITE (March 31, 1993)

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)