FDA 510(k) Applications Submitted by Bisco, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050647 |
03/14/2005 |
ALL-IN-ONE |
BISCO, INC. |
| K060701 |
03/16/2006 |
BISCEM TRANSLUCENT, BISCEM OPAQUE |
BISCO, INC. |
| K051999 |
07/25/2005 |
BISCOVER LED |
BISCO, INC. |
| K052122 |
08/05/2005 |
BISCO LED |
BISCO, INC. |
| K042804 |
10/12/2004 |
TESCERA OPAQUER POWDER/SCULPTING RESIN |
BISCO, INC. |
| K063237 |
10/26/2006 |
THERACAL LC |
BISCO, INC. |
| K033472 |
11/03/2003 |
TESCERA U-BAR AND BARRELS |
BISCO, INC. |
| K033521 |
11/07/2003 |
BISBLOCK |
BISCO, INC. |
| K033585 |
11/13/2003 |
DIAPEX |
BISCO, INC. |
| K043168 |
11/16/2004 |
BISCOVER LV |
BISCO, INC. |
| K073263 |
11/20/2007 |
PRO-V |
BISCO, INC. |
| K063780 |
12/21/2006 |
ACE BOND SE |
BISCO, INC. |
| K034024 |
12/29/2003 |
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS |
BISCO, INC. |
| K003317 |
10/24/2000 |
RENEW LS-1 |
BISCO, INC. |
| K010196 |
01/22/2001 |
TOTAL CURE |
BISCO, INC. |
| K011159 |
04/11/2001 |
ONE-STEP PLUS |
BISCO, INC. |
| K003361 |
10/27/2000 |
RENEW LS-2 |
BISCO, INC. |
| K192007 |
07/29/2019 |
TheraBase, TheraBase Ca |
Bisco, Inc. |
| K970484 |
02/10/1997 |
ACCU-PREP |
BISCO, INC. |
| K961822 |
05/10/1996 |
WET-PREP |
BISCO, INC. |
| K962946 |
07/29/1996 |
ORTHO-ONE |
BISCO, INC. |
| K964000 |
10/07/1996 |
BISFIL 2B |
BISCO, INC. |
| K974483 |
11/26/1997 |
NTL-FLOW |
BISCO, INC. |
| K964931 |
12/10/1996 |
WHITE CORE |
BISCO, INC. |
| K993192 |
08/24/1999 |
ILLUSION |
BISCO, INC. |
| K000426 |
02/09/2000 |
VIP- VARIABLE INTENSITY POLYMERIZER |
BISCO, INC. |
| K992248 |
07/06/1999 |
POST CEMENT HI-X |
BISCO, INC. |
| K993488 |
10/15/1999 |
LIGHT-CORE |
BISCO, INC. |
| K982645 |
07/29/1998 |
PYRAMID |
BISCO, INC. |
| K982729 |
08/05/1998 |
RENEW |
BISCO, INC. |
| K032597 |
08/22/2003 |
BISCEM GI |
BISCO, INC. |
| K012032 |
06/29/2001 |
FIRST SPEP |
BISCO, INC. |
| K141439 |
06/02/2014 |
ORTHODONTIC ACRYLIC (NOT FINALIZED) |
BISCO, INC. |
| K091705 |
06/10/2009 |
PRIMER PLUS |
BISCO, INC. |
| K131734 |
06/13/2013 |
ALL-BOND UNIVERSAL SC (NOT FINALIZED) |
BISCO, INC. |
| K101787 |
06/25/2010 |
DUOLINK II |
BISCO, INC. |
| K112118 |
07/25/2011 |
DREAMBOND |
BISCO, INC. |
| K082449 |
08/25/2008 |
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 |
BISCO, INC. |
| K102844 |
09/29/2010 |
ALL-BOUND 3 |
BISCO, INC. |
| K093470 |
11/06/2009 |
CORE-FLO D/C |
BISCO, INC. |
| K113401 |
11/17/2011 |
ORTHO-1(NOT FINALIZED) |
BISCO, INC. |
| K123653 |
11/27/2012 |
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) |
BISCO, INC. |
| K103514 |
11/30/2010 |
PRO-V COAT |
BISCO, INC. |
| K101485 |
05/28/2010 |
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E |
BISCO, INC. |
| K180344 |
02/08/2018 |
TheraCal DC |
Bisco, Inc. |
| K161051 |
04/14/2016 |
All-Bond Universal w/BAC (not finalized) |
Bisco, Inc. |
| K171147 |
04/19/2017 |
REVEAL Bulk |
Bisco, Inc. |
| K161256 |
05/04/2016 |
TheraCem |
BISCO, INC. |
| K162598 |
09/19/2016 |
HAPI Seal |
BISCO, INC. |
| K163171 |
11/14/2016 |
CeraClean |
Bisco, Inc. |
| K030585 |
02/24/2003 |
SCULPTING RESIN |
BISCO, INC. |
| K024046 |
12/06/2002 |
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P |
BISCO, INC. |
| K030951 |
03/26/2003 |
TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P |
BISCO, INC. |
| K021503 |
05/09/2002 |
UNINHIBITED |
BISCO, INC. |
| K030354 |
02/03/2003 |
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER |
BISCO, INC. |
| K013519 |
10/23/2001 |
SIMPLE |
BISCO, INC. |
| K012180 |
07/12/2001 |
A-WEAR |
BISCO, INC. |
| K984112 |
11/17/1998 |
ADVENT |
BISCO, INC. |
|
|
