Home / 510(k) Clearances / K930614

510(k) K930614

ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST by Wallace A. Erickson & Co. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1993
Date Received
February 5, 1993
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 Wallace A. Erickson & Co.

  • K984503 — ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 (February 26, 1999)
  • K963922 — ALPHA-DENT ROOT CANAL SEALER & FILLER (December 6, 1996)
  • K960667 — CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE (July 2, 1996)
  • K960365 — ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) (March 28, 1996)
  • K960165 — ALPHA-DENT COMPOSITE SURFACE SEALANT (March 15, 1996)
  • K960122 — ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL (February 21, 1996)
  • K955521 — ALPHA-DENT COPAL CAVITY VARNISH (January 24, 1996)
  • K955089 — ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT (December 13, 1995)
  • K942742 — ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV (August 29, 1994)
  • K942727 — ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE (August 23, 1994)

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)