BISCO, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1420052	1420052	BISCO, INC.	1	N	2026-01-01	1100 WEST IRVING PARK RD. Schaumburg IL US 60193

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
80715	1300987178	K993488	LIGHT-CORE	EBF	1999-11-10
80715	1135641782	K993192	ILLUSION	EBF	1999-10-27
80715	1746245927	K984112	ADVENT	EBF	1998-12-22
80715	1743492704	K982729	RENEW	EBF	1998-09-15
80715	1138730603	K964931	WHITE CORE	EBF	1997-02-10
80715	2055356606	K964000	BISFIL 2B	KLE	1996-11-05
80715	1847006555	K962680	HYUNJAE DENTAL IMPRESSION MATERIALS	ELW	1996-09-30
80715	1491602140	K961822	WET-PREP	KLE	1996-06-11
80715	1758533354	K940030	BISCO COMPOSITE	EMA	1994-02-04
80715	1715738911	K934247	BISCO UNIVERSAL HYBRID COMPOSITE	EBF	1993-11-29
80715	2057254651	K930405	BISCO D/C CORE COMPOSITE	EBF	1993-08-24
80715	1300690351	K926238	BISCO PORCELAIN ETCHING GEL	EIH	1993-03-31
80715	1766956208	K915668	BISCO CAVITY CLEANSER	EBF	1992-04-21
80715	2039133175	K910860	ALL-BOND 2	KLE	1991-04-29
80715	1584265345	K882915	FORTIFY	EBF	1988-08-12
80715	1506643089	K875313	PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST	EBF	1988-03-10
80715	1244855089	K875256	BISCOLOR	EBF	1988-02-26
80715	1934169083	K874557	BISCO PORCELAIN REPAIR KIT	EBC	1988-01-28
80715	1571360213	K853002	BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)	EBF	1985-08-16
80715	1245609062	K853001	BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)	EBF	1985-08-16
80715	1817572884	K250156	Choice 2 DC	EMA	2025-07-11
80715	1497111067	K242816	Quantium	EBF	2024-12-17
80715	1356869076	K192007	TheraBase, TheraBase Ca	EMA	2020-03-17
80715	1742574778	K182917	FluoroCal	LBH	2019-11-18
80715	1127714329	K180344	TheraCal DC	EJK	2018-04-05
80715	1284196293	K171147	REVEAL Bulk	EBF	2017-08-04
80715	1329345533	K163171	CeraClean	PME	2017-04-14
80715	1086185501	K161256	TheraCem	EMA	2016-07-29
80715	1116871223	K161051	All-Bond Universal w/BAC (not finalized)	KLE	2016-09-09
80715	1522741155	K131734	ALL-BOND UNIVERSAL SC (NOT FINALIZED)	KLE	2014-04-11
80715	1387072657	K122039	KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B	EBG	2012-12-27
80715	1120456214	K113401	ORTHO-1(NOT FINALIZED)	DYH	2012-02-07
80715	1213355832	K112118	DREAMBOND	KLE	2011-11-17
80715	1435988681	K110796	SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE	DYW	2011-03-31
80715	1606393118	K103514	PRO-V COAT	EBG	2011-05-25
80715	1248827203	K102844	ALL-BOUND 3	KLE	2010-10-29
80715	1557565664	K101787	DUOLINK II	EMA	2010-10-08
80715	1101774055	K101485	ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E	KLE	2010-08-26
80715	1046962260	K093470	CORE-FLO D/C	EBF	2010-02-17
80715	1145030865	K091705	PRIMER PLUS	KLE	2009-08-28
80715	1926531557	K082449	BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012	EMA	2008-09-25
80715	1617027903	K081143	BIOMERS TRANSLUCENT ORTHODONTIC WIRE	DYW	2008-05-02
80715	1023703715	K073263	PRO-V	EBG	2008-02-14
80715	1868371631	K063780	ACE BOND SE	KLE	2007-01-19
80715	1487159368	K063237	THERACAL LC	EJK	2006-12-08
80715	1972823201	K051999	BISCOVER LED	EBD	2005-08-22
80715	1616102194	K042804	TESCERA OPAQUER POWDER/SCULPTING RESIN	EBF	2005-02-01
80715	1714276381	K034024	TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS	EBI	2004-03-19
80715	1748522310	K033521	BISBLOCK	EJK	2004-01-16
80715	1021257204	K030951	TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P	EBF	2003-06-06
80715	2065420121	K030585	SCULPTING RESIN	EBD	2003-04-28
80715	1596823033	K011159	ONE-STEP PLUS	EMA	2001-06-08
80715	1575210575	K003361	RENEW LS-2	EBF	2000-11-28
80715	1287126861
80715	1305014596
80715	1614921005
80715	1709287500
80715	1998985797
80715	1027334391
80715	1053610459
80715	1103410678
80715	1225129081
80715	1237373047
80715	1248865483
80715	1262243481
80715	1289497860
80715	1333495257
80715	1342236484
80715	1415225288
80715	1417258842
80715	1419470638
80715	1422805964
80715	1502958469
80715	1545088646
80715	1569921327
80715	1597737216
80715	1603873740
80715	1635124821
80715	1653917586
80715	1688091799
80715	1717249515
80715	1737625891
80715	1751303071
80715	1813923960
80715	1818796279
80715	1862561102
80715	1882239440
80715	1907076099
80715	1913959335
80715	1936926133
80715	1971787922
80715	1973299815
80715	2032655001

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EBF	19	2024-12-17
KLE	10	2016-09-09
EMA	7	2025-07-11
EJK	3	2018-04-05
EBG	3	2012-12-27
DYW	2	2011-03-31
EBD	2	2005-08-22
LBH	1	2019-11-18
PME	1	2017-04-14
DYH	1	2012-02-07
EBI	1	2004-03-19
ELW	1	1996-09-30
EIH	1	1993-03-31
EBC	1	1988-01-28

PMN#

Quantium
2024-12-17
Bisco, Inc.
TheraBase, TheraBase Ca
2020-03-17
Bisco, Inc.
TheraCal DC
2018-04-05
Bisco, Inc.
REVEAL Bulk
2017-08-04
Bisco, Inc.
HAPI Seal
2017-05-23
BISCO, INC.
CeraClean
2017-04-14
Bisco, Inc.
All-Bond Universal W/BAC (not Finalized)
2016-09-09
Bisco, Inc.
TheraCem
2016-07-29
BISCO, INC.
ORTHODONTIC ACRYLIC (NOT FINALIZED)
2014-09-12
BISCO, INC.
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
2014-04-11
BISCO, INC.
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
2013-06-03
BISCO, INC.
ORTHO-1(NOT FINALIZED)
2012-02-07
BISCO, INC.
DREAMBOND
2011-11-17
BISCO, INC.
PRO-V COAT
2011-05-25
BISCO, INC.
ALL-BOUND 3
2010-10-29
BISCO, INC.
DUOLINK II
2010-10-08
BISCO, INC.
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
2010-08-26
BISCO, INC.
CORE-FLO D/C
2010-02-17
BISCO, INC.
PRIMER PLUS
2009-08-28
BISCO, INC.
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012
2008-09-25
BISCO, INC.
PRO-V
2008-02-14
BISCO, INC.
ACE BOND SE
2007-01-19
BISCO, INC.
THERACAL LC
2006-12-08
BISCO, INC.
BISCEM TRANSLUCENT, BISCEM OPAQUE
2006-05-15
BISCO, INC.
BISCO LED
2006-03-29
BISCO, INC.
BISCOVER LED
2005-08-22
BISCO, INC.
BISCOVER LV
2005-02-01
BISCO, INC.
TESCERA OPAQUER POWDER/SCULPTING RESIN
2005-02-01
BISCO, INC.
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
2004-03-19
BISCO, INC.
BISBLOCK
2004-01-16
BISCO, INC.
DIAPEX
2004-01-16
BISCO, INC.
BISCEM GI
2003-11-04
BISCO, INC.
TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P
2003-06-06
BISCO, INC.
SCULPTING RESIN
2003-04-28
BISCO, INC.
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
2003-02-19
BISCO, INC.
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
2003-02-06
BISCO, INC.
UNINHIBITED
2002-08-01
BISCO, INC.
A-WEAR
2001-09-05
BISCO, INC.
ONE-STEP PLUS
2001-06-08
BISCO, INC.
RENEW LS-2
2000-11-28
BISCO, INC.

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