Medical Device Manufacturer · US , Mchenry , IL

Bisco, Inc.

88 submissions · 88 cleared · Since 1984
88
Total
88
Cleared
0
Denied

Bisco, Inc. — FDA 510(k) Submissions

Bisco, Inc. has submitted 88 FDA 510(k) premarket notifications since 1984, of which 88 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Agent, Tooth Bonding, Resin, Cement, Dental, Coating, Filling Material, Resin, Liner, Cavity, Calcium Hydroxide . Use the specialty filter in the sidebar to narrow results.

88 devices
1–25 of 88
Choice 2 DC
K250156 · EMA Cement, Dental · Dental
Jul 2025 171d
Quantium
K242816 · EBF Material, Tooth Shade, Resin · Dental
Dec 2024 90d
TheraBase, TheraBase Ca
K192007 · EMA Cement, Dental · Dental
Mar 2020 232d
FluoroCal
K182917 · LBH Varnish, Cavity · Dental
Nov 2019 395d
TheraCal DC
K180344 · EJK Liner, Cavity, Calcium... · Dental
Apr 2018 56d
REVEAL Bulk
K171147 · EBF Material, Tooth Shade, Resin · Dental
Aug 2017 107d
HAPI Seal
K162598 · EBC Sealant, Pit And Fissure,... · Dental
May 2017 246d
CeraClean
K163171 · PME External Cleaning Solution · Dental
Apr 2017 151d
All-Bond Universal w/BAC (not finalized)
K161051 · KLE Agent, Tooth Bonding, Resin · Dental
Sep 2016 148d
TheraCem
K161256 · EMA Cement, Dental · Dental
Jul 2016 86d
TheraCal DC
K143292 · EJK Liner, Cavity, Calcium... · Dental
Aug 2015 260d
ORTHODONTIC ACRYLIC (NOT FINALIZED)
K141439 · EBI Resin, Denture, Relining,... · Dental
Sep 2014 102d
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · KLE Agent, Tooth Bonding, Resin · Dental
Apr 2014 302d
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · LBH Varnish, Cavity · Dental
Jun 2013 188d
ORTHO-1(NOT FINALIZED)
K113401 · DYH Adhesive, Bracket And... · Dental
Feb 2012 82d
DREAMBOND
K112118 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2011 115d
PRO-V COAT
K103514 · EBG Crown And Bridge,... · Dental
May 2011 176d
ALL-BOUND 3
K102844 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2010 30d
DUOLINK II
K101787 · EMA Cement, Dental · Dental
Oct 2010 105d
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
K101485 · KLE Agent, Tooth Bonding, Resin · Dental
Aug 2010 90d
CORE-FLO D/C
K093470 · EBF Material, Tooth Shade, Resin · Dental
Feb 2010 103d
PRIMER PLUS
K091705 · KLE Agent, Tooth Bonding, Resin · Dental
Aug 2009 79d
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012
K082449 · EMA Cement, Dental · Dental
Sep 2008 31d
PRO-V
K073263 · EBG Crown And Bridge,... · Dental
Feb 2008 86d
ACE BOND SE
K063780 · KLE Agent, Tooth Bonding, Resin · Dental
Jan 2007 29d

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