BISCO, INC.

FDA Device Registration & Listing · Schaumburg, IL, US · Registration 1420052

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1420052
FEI Number
1420052
Entity Name
BISCO, INC.
City/State/Country
Schaumburg, IL, US
Establishment Address
1100 WEST IRVING PARK RD., Schaumburg, IL 60193, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BISCO, INC. (Owner Number: 1420052)
Owner / Operator Contact Address
1100 WEST IRVING PARK RD., --, Schaumburg, IL 60193, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Uni-Etch Accessories Auto-Mix Cannula Tips Flowable Syringe Tips Etch-37 Accessories NEEDLE BRUSH TIPS DUAL-SYRINGE INTRA-ORAL MIXING TIPS DUAL-SYRINGE ROOT CANAL MIXING TIPS UNIT-DOSE DISPENSING SYRINGE AELITEFLO ANGLED TIPS SELECT HV ETCH ACCESSORIES BLUE TIP DUAL-SYRINGE DISPENSER DUAL-SYRINGE STATIC MIXING TIP NEEDLE TIP/PLUG L/V TIP/PLUG AELITEFLO LV TIPS AELITE AESTHETIC ENAMEL ETCH-37 with BAC SELECT HV ETCH with BAC UNI-ETCH UNI-ETCH with BAC SELECT HV ETCH ETCH-37 ORTHO-ONE LIQUID ETCHANT Choice 2 DC Z-PRIME PLUS AQUA-PREP F All-Bond Universal w/BAC ZirClean PORCELAIN ETCHANT 9.5% PORCELAIN ETCHANT 4% BARRIER GEL LIGHT CORE ONE-STEP PLUS ONE-STEP Z-CEM SA BISCEM TheraCem TheraCem Ca AELITE LS PACKABLE ENAMEL AELITEFLO TESCERA FLO Quantium BISFIL 2B FORTIFY MODELING RESIN MIXING PAD DISPOSABLE MIXING WELLS RESINVOIR MIXING WELL BISCO APPLICATORS DISPOSABLE SPATULAS HANDLES BISCO BRISTLE APPLICATOR BRUSH TIPS eCement (Light-Cured Resin Cement) CHOICE 2 PORCELAIN BONDING RESIN CHOICE Universal Primer TESCERA OPAQUER POWDER TESCERA OPAQUER/SCULPTING RESIN PORCELAIN PRIMER OPAQUER D/C BIS-SILANE ALL-BOND 3 ALL-BOND UNIVERSAL DUO-LINK DUO-LINK UNIVERSAL eCement (Dual-Cured Resin Cement) AELITE LS PACKABLE DENTIN AELITE LS POSTERIOR THERACAL LC eCEMENT Try-In-Paste Choice 2 Try-in-Paste

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EMA Cement, Dental Dental Class 2 872.3275 2012-12-18
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2011-11-17
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
LBH Varnish, Cavity Dental Class 2 872.3260 2014-03-17
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2012-12-19
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2010-08-30
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-03-06
NXC Aligner, Sequential Dental Class 2 872.5470 2013-04-15
EMA Cement, Dental Dental Class 2 872.3275 2025-12-18
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2009-09-03
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-12
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2016-10-26
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
PME External Cleaning Solution Dental Class 2 872.3260 2017-04-20
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2012-12-19
EMA Cement, Dental Dental Class 2 872.3275 2007-11-12
EMA Cement, Dental Dental Class 2 872.3275 2008-10-14
EMA Cement, Dental Dental Class 2 872.3275 2016-08-01
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2025-01-08
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2012-12-18
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2020-10-14
EMA Cement, Dental Dental Class 2 872.3275 2020-10-14
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2007-11-12
KXR Applicator, Resin Dental Class 1 872.3140 2011-11-17
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2014-09-24
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2023-08-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2021-09-02
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-12
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2012-12-18
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2007-11-12
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2007-11-12
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2010-11-08
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-12-06
EMA Cement, Dental Dental Class 2 872.3275 2010-11-08
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-02-26
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2011-09-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-12
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BISCO, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09
K940030 Bisco, Inc. BISCO COMPOSITE 1994-02-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1420052. Last updated year: 2026. Please use registration number 1420052 when referencing this establishment in official correspondence.
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