Bisco Inc
Schaumburg, IL, US
BISCO, INC. appears in FDA device records in Schaumburg, IL. FDA records list 57 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Bisco Inc between 1998 and 2025. The busiest year on record is 2003, with 5. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 4 |
| 1999 | 3 |
| 2000 | 3 |
| 2001 | 4 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 4 |
| 2005 | 4 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 4 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250156 | Choice 2 DC | EMA | Substantially Equivalent | |
| K242816 | Quantium | EBF | Substantially Equivalent | |
| K192007 | TheraBase, TheraBase Ca | EMA | Substantially Equivalent | |
| K182917 | FluoroCal | LBH | Substantially Equivalent | |
| K180344 | TheraCal DC | EJK | Substantially Equivalent | |
| K171147 | REVEAL Bulk | EBF | Substantially Equivalent | |
| K162598 | HAPI Seal | EBC | Substantially Equivalent | |
| K163171 | CeraClean | PME | Substantially Equivalent | |
| K161051 | All-Bond Universal w/BAC (not finalized) | KLE | Substantially Equivalent | |
| K161256 | TheraCem | EMA | Substantially Equivalent | |
| K143292 | TheraCal DC | EJK | Substantially Equivalent | |
| K141439 | ORTHODONTIC ACRYLIC (NOT FINALIZED) | EBI | Substantially Equivalent | |
| K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) | KLE | Substantially Equivalent | |
| K123653 | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) | LBH | Substantially Equivalent | |
| K113401 | ORTHO-1(NOT FINALIZED) | DYH | Substantially Equivalent | |
| K112118 | DREAMBOND | KLE | Substantially Equivalent | |
| K103514 | PRO-V COAT | EBG | Substantially Equivalent | |
| K102844 | ALL-BOUND 3 | KLE | Substantially Equivalent | |
| K101787 | DUOLINK II | EMA | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K093470 | CORE-FLO D/C | EBF | Substantially Equivalent | |
| K091705 | PRIMER PLUS | KLE | Substantially Equivalent | |
| K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 | EMA | Substantially Equivalent | |
| K073263 | PRO-V | EBG | Substantially Equivalent | |
| K063780 | ACE BOND SE | KLE | Substantially Equivalent | |
| K063237 | THERACAL LC | EJK | Substantially Equivalent | |
| K060701 | BISCEM TRANSLUCENT, BISCEM OPAQUE | EMA | Substantially Equivalent | |
| K052122 | BISCO LED | EBZ | Substantially Equivalent | |
| K051999 | BISCOVER LED | EBD | Substantially Equivalent | |
| K050647 | ALL-IN-ONE | KLE | Substantially Equivalent | |
| K043168 | BISCOVER LV | EBD | Substantially Equivalent | |
| K042804 | TESCERA OPAQUER POWDER/SCULPTING RESIN | EBF | Substantially Equivalent | |
| K034024 | TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS | EBI | Substantially Equivalent | |
| K033585 | DIAPEX | KIF | Substantially Equivalent | |
| K033521 | BISBLOCK | EJK | Substantially Equivalent | |
| K033472 | TESCERA U-BAR AND BARRELS | EBI | Substantially Equivalent | |
| K032597 | BISCEM GI | EMA | Substantially Equivalent | |
| K030951 | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P | EBF | Substantially Equivalent | |
| K030585 | SCULPTING RESIN | EBD | Substantially Equivalent | |
| K030354 | BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER | EBD | Substantially Equivalent | |
| K024046 | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P | EBD | Substantially Equivalent | |
| K021503 | UNINHIBITED | EBD | Substantially Equivalent | |
| K013519 | SIMPLE | KLE | Substantially Equivalent | |
| K012032 | FIRST SPEP | DYH | Substantially Equivalent | |
| K012180 | A-WEAR | EBF | Substantially Equivalent | |
| K011159 | ONE-STEP PLUS | EMA | Substantially Equivalent | |
| K010196 | TOTAL CURE | EBF | Substantially Equivalent | |
| K003361 | RENEW LS-2 | EBF | Substantially Equivalent | |
| K003317 | RENEW LS-1 | EBF | Substantially Equivalent | |
| K000426 | VIP- VARIABLE INTENSITY POLYMERIZER | EBZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1420052 | 1420052 | BISCO, INC. | 1100 WEST IRVING PARK RD., Schaumburg, IL 60193 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- KLEAgent, Tooth Bonding, Resin
- NXCAligner, Sequential
- KXRApplicator, Resin
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- PMEExternal Cleaning Solution
- EJKLiner, Cavity, Calcium Hydroxide
- EBFMaterial, Tooth Shade, Resin
- EIHPowder, Porcelain
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- EBCSealant, Pit And Fissure, And Conditioner
- EIDSyringe, Restorative And Impression Material
- LBHVarnish, Cavity
- EGDWax, Dental, Intraoral
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1697-2008 | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp. | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time. | Terminated | ||
| Z-1696-2008 | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp. | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain