Home / 510(k) Clearances / K173020

510(k) K173020

OBA-MCP, Orthodontic Bracket Adhesive with MCP by Pulpdent Corporation — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2018
Date Received
September 28, 2017
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 Pulpdent Corporation

  • K210045 — ACTIVA PRESTO PACK (September 22, 2021)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K153249 — Pulpdent Solo Flowable Composite with MCP (April 1, 2016)
  • K130223 — RMGI FILL (March 29, 2013)
  • K123265 — RMGI LOW VISCOSITY (December 7, 2012)
  • K120784 — TUFF-TEMP 2.0 (June 8, 2012)
  • K120003 — NUCAL (April 5, 2012)
  • K120213 — ETCH-RITE SUPREME (March 30, 2012)
  • K113818 — EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (March 21, 2012)
  • K113711 — LIME-LITE II (March 5, 2012)

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)