Home / 510(k) Clearances / K142886

510(k) K142886

DMRC Self-Cure Bracket Adhesive One Step and Primer by Danville Materials, LLC — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2015
Date Received
October 2, 2014
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 Danville Materials, LLC

  • K152349 — Star+ VPS Scannable Impression Material (November 23, 2015)
  • K151514 — Prestige (September 21, 2015)
  • K151088 — DMRC Bulk Fill (August 28, 2015)
  • K142881 — DMRC Dual Cure Orthodontic Band Cement (February 13, 2015)
  • K121880 — DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID (September 25, 2012)
  • K111876 — Z BOND, PRELUDE ONE (September 21, 2011)
  • K110642 — SILJETR SYSTEM (May 27, 2011)
  • K102753 — TURBO TEMP 3 (February 4, 2011)
  • K092912 — STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW V (December 16, 2009)
  • K092319 — STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 (September 16, 2009)

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)