Bisco Inc

FDA Filings

This page includes the latest FDA filings for Bisco Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1420052
FEI Number1420052
NameBISCO, INC.
Owner & OperatorBISCO, INC.
Contact Address1100 WEST IRVING PARK RD. --
Schaumburg IL 60193 US
Official Correspondent
  • BYOUNG I SUH
  • x-847-5346000-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1100 WEST IRVING PARK RD.
Schaumburg, IL 60193 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
BISCO INC.
 TheraCal PT H-34111P2024-04-11
BISCO INC.
 TheraCal PT H-341112024-04-11
BISCO INC.
 Ace All-Bond SE Cartridge-Pouch U-302112024-02-16
BISCO INC.
 All-Bond SE Bottle Kit U-30120K2024-02-16
BISCO INC.
 All-Bond SE Liner 1.5g Syr. U-30122024-02-16
BISCO INC.
 All-Bond SE Liner 3ml Btl Smpl U-3011S2024-02-16
BISCO INC.
 All-Bond SE Part II 6ml in Bag U-3002P2024-02-16
BISCO INC.
 All-Bond SE Part I 6ml in Bag U-3001P2024-02-16
BISCO INC.
 One Step Plus KIT U-2260K2024-02-16
BISCO INC.
 One Step Plus U/D (60) KIT U-20210K2024-02-16
BISCO INC.
 ONE-STEP Plus Adh. 2ml SMPL U-2002S2024-02-16
BISCO INC.
 ONE-STEP 2ml SAMPLE PACKAGE U-1103P2024-02-16
BISCO INC.
 ONE-STEP ADHESIVE 2ml SAMPLE U-11032024-02-16
BISCO INC.
 ORTHO-ONE No Mix Adh Kit F-6100D2024-02-16
BISCO INC.
 A.B. Universal - Bag of 50 B-7350P2024-02-16
BISCO INC.
 A.B. Universal Unit Dose .20ml - Reliance Version B-7301R2024-02-16
BISCO INC.
 Ace Universal Primer A&B 4 Cartridges PKG B-41240P2024-02-16
BISCO INC.
 Ace Universal Primer A&B 1Cartridge PKG B-41210P2024-02-16
BISCO INC.
 Ace Universal Primer A&B Cartridge-Pouch B-412012024-02-16
BISCO INC.
 ACE All-Bond TE Starter Kit B-36100K2024-02-16
BISCO INC.
 ACE-All-Bond TE 1 CartridgePkg B-3605PS2024-02-16
BISCO INC.
 Ace All-Bond TE 4 Cartrdg Pkg B-36050P2024-02-16
BISCO INC.
 Ace All-Bond TE Cartrdg(Pouch) B-36052024-02-16
BISCO INC.
 PRE-BOND Resin 3ml Btl B-2501A2024-02-16
BISCO INC.
 FluoroCal B-30507K2023-12-19
BISCO INC.
 FluoroCal B-3004PS2023-12-19
BISCO INC.
 FluoroCal B-30504K2023-12-19
BISCO INC.
 FluoroCal B-30502K2023-12-19
BISCO INC.
 Disposable Mixing Well 48/PK-Double Well X-80496B2023-05-04
BISCO INC.
 Disp. Mixing Well, #A-868 MXWL-0082023-05-04
BISCO INC.
 Disp. Mixing Well #5901 MXWL-0072023-05-04
BISCO INC.
 Accessory X-80496B2023-05-04
BISCO INC.
 Accessory X-81267P2022-12-06
BISCO INC.
 Accessory X-81257P2022-12-06
BISCO INC.
 Z-Cem SA D-470212022-12-06
BISCO INC.
 IntraOral DualSyrMixgTip 30-PK X-81257P2022-11-29
BISCO INC.
 Z-Cem SA D-470212022-11-29
BISCO INC.
 Accessory X-812662022-11-29
BISCO INC.
 Accessory X-81258S2022-11-29
BISCO INC.
 Accessory X-812552022-11-29
BISCO INC.
 Accessory X-80622N2022-11-29
BISCO INC.
 Accessory X-80608N2022-11-29
BISCO INC.
 Accessory X-80497P2022-11-29
BISCO INC.
 Accessory X-80251P2022-11-29
BISCO INC.
 Aeliteflo H-674D3F2022-11-29
BISCO INC.
 Reveal HD Bulk H-9334B12022-11-25
BISCO INC.
 Aelite LS Posterior H-722A32022-11-25
BISCO INC.
 Cavity Cleanser B-28072022-11-25
BISCO INC.
 eCement C-52232022-11-25
BISCO INC.
 All-Bond 2 B-25022022-11-25
BISCO INC.
 Choice 2 C-411OP2022-11-25
BISCO INC.
 eCement C-523402022-11-25
BISCO INC.
 Porcelain Etchant E-5701E2022-11-25
BISCO INC.
 Select HV Etch E-59100K2022-11-25
BISCO INC.
 Aeliteflo H-675OW2022-11-25
BISCO INC.
 TheraCal LC H-3301P2022-11-25
BISCO INC.
 New Tips Packaging II X-812552022-11-22
BISCO INC.
 22G Black Tip, 15ea/Bag X-80622N2022-11-22
BISCO INC.
 22G Black 50eaPkg w/Label X-80621N2022-11-22
BISCO INC.
 22G D Blue Tip 50eaPkg w/Label X-80608N2022-11-22
BISCO INC.
 Disposable Mixing Well 48/PK-Single Well X-80497P2022-11-22
BISCO INC.
 OrangeHandle Microbrush 25/pk X-80251P2022-11-22
BISCO INC.
 OrangeHandle Microbrush 100pcs Pkg X-80250P2022-11-22
BISCO INC.
 Reveal HD Bulk H-9334A22022-11-11
BISCO INC.
 Reveal HD Bulk H-9334A12022-11-11
BISCO INC.
 Accessory X-806052022-11-11
BISCO INC.
 eCement Try-In Paste C-531TR2022-11-11
BISCO INC.
 eCement Try-In Paste C-531A12022-11-11
BISCO INC.
 Light-Core A-1725P2022-11-11
BISCO INC.
 All-Bond 3 B-36200K2022-11-11
BISCO INC.
 Aeliteflo H-671A2OF2022-11-11
BISCO INC.
 25G Blue Tip, 30ea/Bag X-806052022-11-04
BISCO INC.
 ENDO Brushes (50ea) X-80243R2022-11-04
BISCO INC.
 Aelite Aesthetic Enamel H-854CL2022-10-21
BISCO INC.
 Aeliteflo H-675TI2022-10-21
BISCO INC.
 Aeliteflo H-672B1F2022-10-21
BISCO INC.
 Aeliteflo H-671A2O2022-10-21
BISCO INC.
 Light-Core A-17282022-10-20
BISCO INC.
 All-Bond 3 B-36082022-10-20
BISCO INC.
 FluoroCal B-30501K2022-10-20
BISCO INC.
 Universal Primer B-41022022-10-20
BISCO INC.
 Universal Primer B-41012022-10-20
BISCO INC.
 Select HV Etch w/BAC E-59162022-10-19
BISCO INC.
 Choice 2 C-411A32022-10-19
BISCO INC.
 Select HV Etch E-59012022-10-19
BISCO INC.
 Select HV Etch w/BAC E-59200K2022-10-19
BISCO INC.
 Etch-37 w/BAC E-5638EB2022-10-19
BISCO INC.
 Uni-Etch E-5622E2022-10-19
BISCO INC.
 Uni-Etch w/BAC E-5637EB2022-10-19
BISCO INC.
 Choice 2 Try-In Paste C-412B12022-10-19
BISCO INC.
 Choice 2 Try-In Paste C-412A3P2022-10-19
BISCO INC.
 Choice 2 C-39010K2022-10-19
BISCO INC.
 All-Bond Universal B-72020K2022-10-19
BISCO INC.
 All-Bond Universal B-73100K2022-10-19
BISCO INC.
 All-Bond Universal B-73050K2022-10-19
BISCO INC.
 Aeliteflo H-672B12022-10-19
BISCO INC.
 Aeliteflo H-671A35F2022-10-19
BISCO INC.
 Aeliteflo H-671A352022-10-19
BISCO INC.
 Aeliteflo H-671A12022-10-19
BISCO INC.
 Porcelain Primer B-22232022-10-19
Bisco, Inc.
TheraBase, TheraBase Ca2020-03-17
BISCO, INC.
FluoroCal2020-01-10
Bisco, Inc
FluoroCal2019-11-18
BISCO, INC.
TheraCal PT2018-04-09
BISCO, INC.
TheraCal DC2018-04-09
Bisco, Inc.
TheraCal DC2018-04-05
BISCO, INC.
REVEAL HD Bulk2017-08-07
Bisco, Inc.
REVEAL Bulk2017-08-04
BISCO, INC.
HAPI Seal2017-05-23
BISCO, INC.
ZirClean2017-04-20
Bisco, Inc.
CeraClean2017-04-14
BISCO, INC.
All-Bond Universal w/BAC2016-10-26
Bisco, Inc.
All-Bond Universal W/BAC (not Finalized)2016-09-09
BISCO, INC.
TheraCem2016-08-01
BISCO, INC.
TheraCem Ca2016-08-01
BISCO, INC.
TheraCem2016-07-29
Bisco Inc
TheraCal DC2015-08-04
BISCO, INC.
BisCore2015-07-22
BISCO, INC.
BisFil II2015-07-22
BISCO, INC.
Pro-V Coat2015-07-22
BISCO, INC.
Universal Primer2014-09-24
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.
LIGHT CORE2012-12-19
BISCO, INC.
Ortho Bracket2012-12-18
BISCO, INC.
ORTHO-ONE2012-03-06
BISCO, INC.
LIQUID ETCHANT2012-03-06
BISCO, INC.
ORTHO-1(NOT FINALIZED)2012-02-07
BISCO, INC.
ALL-BOND UNIVERSAL2011-12-06
BISCO, INC.
DREAMBOND2011-11-17
BISCO, INC.
RESINVOIR MIXING WELL2011-11-17
BISCO, INC.
MIXING PAD2011-11-17
BISCO, INC.
HANDLES2011-11-17
BISCO, INC.
DISPOSABLE SPATULAS2011-11-17
BISCO, INC.
DISPOSABLE MIXING WELLS2011-11-17
BISCO, INC.
BRUSH TIPS2011-11-17
BISCO, INC.
BISCO BRISTLE APPLICATOR2011-11-17
BISCO, INC.
BISCO APPLICATORS2011-11-17
BISCO, INC.
TESCERA POLISHING PASTE2011-11-17
BISCO, INC.
FINISHING DISCS2011-11-17
BISCO, INC.
RAPTOR2011-11-17
BISCO, INC.
LI'L RAPTORS2011-11-17
BISCO, INC.
UNIT-DOSE DISPENSING SYRINGE2011-11-17
BISCO, INC.
SELECT HV ETCH ACCESSORIES2011-11-17
BISCO, INC.
NEEDLE TIP/PLUG2011-11-17
BISCO, INC.
NEEDLE BRUSH TIPS2011-11-17
BISCO, INC.
L/V TIP/PLUG2011-11-17
BISCO, INC.
INTRA-ORAL MIXING TIP2011-11-17
BISCO, INC.
DUAL-SYRINGE STATIC MIXING TIP2011-11-17
BISCO, INC.
DUAL-SYRINGE ROOT CANAL MIXING TIPS2011-11-17
BISCO, INC.
DUAL-SYRINGE DISPENSER2011-11-17
BISCO, INC.
BLUE TIP2011-11-17
BISCO, INC.
AELITEFLO LV TIPS2011-11-17
BISCO, INC.
AELITEFLO ANGLED TIPS2011-11-17
BISCO, INC.
ACE DISPENSER2011-11-17
BISCO, INC.
Tescera Instruments2011-11-17
BISCO, INC.
RAP Reverse Action Pliers2011-11-17
BISCO, INC.
NB Instruments2011-11-17
BISCO, INC.
THERACAL LC2011-09-12
BISCO, INC.
PRO-V COAT2011-05-25
BISCO, INC.
ALL-BOND TE2010-11-08
BISCO, INC.
ALL-BOND 32010-11-08
BISCO, INC.
ACE ALL-BOND TE2010-11-08
BISCO, INC.
eCement (Dual-Cured Resin Cement)2010-11-08
BISCO, INC.
DUO-LINK2010-11-08
BISCO, INC.
DUO-LINK UNIVERSAL2010-11-08
BISCO, INC.
ALL-BOUND 32010-10-29
BISCO, INC.
DUOLINK II2010-10-08
BISCO, INC.
UNI-ETCH2010-08-30
BISCO, INC.
UNI-ETCH with BAC2010-08-30
BISCO, INC.
SELECT HV ETCH2010-08-30
BISCO, INC.
SELECT HV ETCH with BAC2010-08-30
BISCO, INC.
ETCH-372010-08-30
BISCO, INC.
ETCH-37 with BAC2010-08-30
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- E2010-08-26
BISCO, INC.
Core-Flo DC Lite2010-03-11
BISCO, INC.
CORE-FLO DC2010-03-11
BISCO, INC.
CORE-FLO D/C2010-02-17
BISCO, INC.
Z-PRIME PLUS2009-09-03
BISCO, INC.
PRIMER PLUS2009-08-28
BISCO, INC.
AELITE LS POSTERIOR2009-02-26
BISCO, INC.
AELITE LS PACKABLE DENTIN2009-02-26
BISCO, INC.
Z-CEM SA2008-10-14
BISCO, INC.
BISCEM2008-10-14
BISCO, INC.
PRO-V FILL2008-10-14
BISCO, INC.
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-450122008-09-25
BISCO, INC.
PRO-V2008-02-14
BISCO, INC.
eCEMENT Try-In-Paste2007-11-12
BISCO, INC.
Choice 2 Try-in-Paste2007-11-12
BISCO, INC.
TESCERA ROOT DENTIN2007-11-12
BISCO, INC.
TESCERA INCISAL2007-11-12
BISCO, INC.
TESCERA ENAMEL2007-11-12
BISCO, INC.
TESCERA DENTIN2007-11-12
BISCO, INC.
TESCERA COLOR MODIFIER2007-11-12
BISCO, INC.
TESCERA CHROMA2007-11-12
BISCO, INC.
TESCERA BODY2007-11-12
BISCO, INC.
REVEAL2007-11-12
BISCO, INC.
AELITE ALL-PURPOSE BODY2007-11-12
BISCO, INC.
CORE-FLO2007-11-12
BISCO, INC.
BISFIL 2B2007-11-12
BISCO, INC.
Reveal Clear Matrix2007-11-12
BISCO, INC.
Quick-Die2007-11-12
BISCO, INC.
AQUA-PREP F2007-11-12
BISCO, INC.
C&B2007-11-12
BISCO, INC.
AELITE LS PACKABLE ENAMEL2007-11-12
BISCO, INC.
PORCELAIN ETCHANT 9.5%2007-11-12
BISCO, INC.
PORCELAIN ETCHANT 4%2007-11-12
BISCO, INC.
BARRIER GEL2007-11-12
BISCO, INC.
RESINOMER2007-11-12
BISCO, INC.
Ortho Band2007-11-12
BISCO, INC.
CAVITY CLEANSER2007-11-12
BISCO, INC.
FORTIFY2007-11-12
BISCO, INC.
FORTIFY PLUS2007-11-12
BISCO, INC.
eCement (Light-Cured Resin Cement)2007-11-12
BISCO, INC.
PORCELAIN BONDING RESIN2007-11-12
BISCO, INC.
CHOICE2007-11-12
BISCO, INC.
CHOICE 22007-11-12
BISCO, INC.
CHARACTERIZATION TINT2007-11-12
BISCO, INC.
PORCELAIN REPAIR KIT2007-11-12
BISCO, INC.
PORCELAIN PRIMER2007-11-12
BISCO, INC.
OPAQUER D/C2007-11-12
BISCO, INC.
BIS-SILANE2007-11-12
BISCO, INC.
AELITE AESTHETIC ENAMEL2007-11-12
BISCO, INC.
BISCOVER LV2007-11-12
BISCO, INC.
TESCERA OPAQUER/SCULPTING RESIN2007-11-12
BISCO, INC.
TESCERA OPAQUER POWDER2007-11-12
BISCO, INC.
TESCERA FIBER MESH2007-11-12
BISCO, INC.
TESCERA FIBER CYLINDER2007-11-12
BISCO, INC.
TESCERA FIBER BUNDLES2007-11-12
BISCO, INC.
BISBLOCK2007-11-12
BISCO, INC.
TESCERA FLO2007-11-12
BISCO, INC.
AELITEFLO2007-11-12
BISCO, INC.
AELITEFLO LV2007-11-12
BISCO, INC.
MODELING RESIN2007-11-12
BISCO, INC.
ONE-STEP2007-11-12
BISCO, INC.
ONE-STEP PLUS2007-11-12
BISCO, INC.
PRE-BOND2007-11-09
BISCO, INC.
D/E RESIN2007-11-09
BISCO, INC.
ALL-BOND SE LINER2007-11-09
BISCO, INC.
ALL-BOND 3 RESIN2007-11-09
BISCO, INC.
ALL-BOND 22007-11-09
BISCO, INC.
All-Bond SE2007-11-09
BISCO, INC.
ACE All-Bond SE2007-11-09
BISCO, INC.
ACE BOND SE2007-01-19
BISCO, INC.
THERACAL LC2006-12-08
BISCO, INC.
BISCEM TRANSLUCENT, BISCEM OPAQUE2006-05-15
BISCO, INC.
BISCO LED2006-03-29
BISCO, INC.
BISCOVER LED2005-08-22
BISCO, INC.
BISCOVER LV2005-02-01
BISCO, INC.
TESCERA OPAQUER POWDER/SCULPTING RESIN2005-02-01
BISCO, INC.
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS2004-03-19
BISCO, INC.
DIAPEX2004-01-16
BISCO, INC.
BISBLOCK2004-01-16
BISCO, INC.
BISCEM GI2003-11-04
BISCO, INC.
TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P2003-06-06
BISCO, INC.
SCULPTING RESIN2003-04-28
BISCO, INC.
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER2003-02-19
BISCO, INC.
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P2003-02-06
BISCO, INC.
UNINHIBITED2002-08-01
BISCO, INC.
A-WEAR2001-09-05
BISCO, INC.
ONE-STEP PLUS2001-06-08
BISCO, INC.
Transluma2000-12-27
BISCO, INC.
DT Light-Post Illusion XR-O2000-12-27
BISCO, INC.
DT Light Post2000-12-27
BISCO, INC.
DT Light Post Illusion2000-12-27
BISCO, INC.
C-Post2000-12-27
BISCO, INC.
Transluma Drill (refill)2000-12-27
BISCO, INC.
DT Drill2000-12-27
BISCO, INC.
RENEW LS-22000-11-28
BISCO, INC.
RENEW LS-12000-11-21
BISCO, INC.
VIP- VARIABLE INTENSITY POLYMERIZER2000-04-12
BISCO, INC.
LIGHT-CORE1999-11-10
BISCO, INC.
ILLUSION1999-10-27
BISCO, INC.
POST CEMENT HI-X1999-08-25
BISCO, INC.
ADVENT1998-12-22
BISCO, INC.
RENEW1998-09-15
BISCO, INC.
PYRAMID1998-09-02
BISCO, INC.
NTL-FLOW1998-02-09
BISCO, INC.
ACCU-PREP1997-07-01
BISCO, INC.
WHITE CORE1997-02-10
BISCO, INC.
BISFIL 2B1996-11-05
BISCO, INC.
ORTHO-ONE1996-09-03
BISCO, INC.
WET-PREP1996-06-11
BISCO, INC.
AELITEFLO1995-12-13
BISCO, INC.
C-POST1995-03-31
BISCO, INC.
ECLIPTOMER1995-01-03
BISCO, INC.
BISCO COMPOSITE1994-02-04
BISCO, INC.
BISCO DUO LINK D/C LUTING COMPOSITE1994-01-26
BISCO, INC.
BISCO UNIVERSAL HYBRID COMPOSITE1993-11-29
BISCO, INC.
BISCO D/C CORE COMPOSITE1993-08-24
BISCO, INC.
ALL-BOND(R) JR.1993-07-22
BISCO, INC.
BISCO PORCELAIN ETCHING GEL1993-03-31
BISCO, INC.
BISCO D/C RESINOMER1992-12-28
BISCO, INC.
BISCO UNIVERSAL BOND-31992-09-29
BISCO, INC.
BISCO CORE PASTE1992-05-11
BISCO, INC.
BISCO CAVITY CLEANSER1992-04-21
BISCO, INC.
ALL-BOND 21991-04-29
BISCO, INC.
ALL BOND LINER-F1991-03-29
BISCO, INC.
ALL-BOND DENTIN BONDING SYSTEM1990-03-14
BISCO, INC.
ORTHO-SEAL1988-10-12
BISCO, INC.
FORTIFY1988-08-12
BISCO, INC.
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST1988-03-10
BISCO, INC.
BISCOLOR1988-02-26
BISCO, INC.
BISCO PORCELAIN REPAIR KIT1988-01-28
BISCO, INC.
BISCO PIT AND FISSURE SEALANT1988-01-28
BISCO, INC.
BISCO'S PORCELAIN VENEER SYSTEM1986-04-30
BISCO, INC.
BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)1985-08-16
BISCO, INC.
BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)1985-08-16
BISCO, INC.
BISFIL-I LIGHT CURABLE POSTERIOR COMPO1984-07-12

Related Finance Registrations
NCAGE Code0SPV4BISCO INC
CAGE Code0SPV4BISCO INC
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020083169565Pusan,South Korea -> Los Angeles, CaliforniaBARIUM GLASS POWDER 3824.9910 PKG
2020072759000Pusan,South Korea -> Los Angeles, CaliforniaSTRONTIUM GLASS POWDER 3824.9910 PKG
201905241551Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTUBES HTS 3926903 PKG
201905062920Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTUBES HTS 3926903 PKG
201905022645Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTUBES HTS 3926903 PKG
201904304786Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTUBES HTS 3926903 PKG
201904268897Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTUBES HTS 3926903 PKG
2019041627850Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTUBES HTS 3926903 PKG
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