Data / Medical devices / United States / Bisco, Inc.
Bisco, Inc.: FDA-registered device maker in Schaumburg, IL, United States, 37 510(k) clearances
Bisco, Inc. is registered with the FDA (registration 1420052) in Schaumburg, IL, United States. It lists 15 device types. The FDA files 37 510(k) clearances under its listings, the newest dated July 11, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1420052
- Address
- 1100 West Irving Park RD., Schaumburg, IL, United States, 60193
- Owner or operator
- BISCO, INC. (1420052)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 9, 2007
- Registered through
- 2027
- Brand names listed
- AELITE AESTHETIC ENAMEL, AELITE ALL-PURPOSE BODY, AELITE LS PACKABLE DENTIN, AELITE LS PACKABLE ENAMEL, AELITE LS POSTERIOR, AELITEFLO, AELITEFLO ANGLED TIPS, AELITEFLO LV TIPS and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2025 | K250156 | Choice 2 DC | EMA | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| December 17, 2024 | K242816 | Quantium | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| March 17, 2020 | K192007 | TheraBase, TheraBase Ca | EMA | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| April 5, 2018 | K180344 | TheraCal DC | EJK | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| April 14, 2017 | K163171 | CeraClean | PME | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161051 | All-Bond Universal w/BAC (not finalized) | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| July 29, 2016 | K161256 | TheraCem | EMA | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| April 11, 2014 | K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| February 7, 2012 | K113401 | ORTHO-1(NOT FINALIZED) | DYH | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| November 17, 2011 | K112118 | DREAMBOND | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| October 29, 2010 | K102844 | ALL-BOUND 3 | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| October 8, 2010 | K101787 | DUOLINK II | EMA | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| August 26, 2010 | 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 | Bisco, Inc. | accessdata.fda.gov |
| February 17, 2010 | K093470 | CORE-FLO D/C | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| August 28, 2009 | K091705 | PRIMER PLUS | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| September 25, 2008 | K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 | EMA | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| December 8, 2006 | K063237 | THERACAL LC | EJK | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| February 1, 2005 | K042804 | TESCERA OPAQUER POWDER/SCULPTING RESIN | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| June 6, 2003 | K030951 | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| April 28, 2003 | K030585 | SCULPTING RESIN | EBD | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| June 8, 2001 | K011159 | ONE-STEP PLUS | EMA | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| November 28, 2000 | K003361 | RENEW LS-2 | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| November 10, 1999 | K993488 | LIGHT-CORE | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| October 27, 1999 | K993192 | ILLUSION | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| December 22, 1998 | K984112 | ADVENT | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| September 15, 1998 | K982729 | RENEW | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| November 5, 1996 | K964000 | BISFIL 2B | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| June 11, 1996 | K961822 | WET-PREP | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| November 29, 1993 | K934247 | BISCO UNIVERSAL HYBRID COMPOSITE | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| March 31, 1993 | K926238 | BISCO PORCELAIN ETCHING GEL | EIH | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| April 21, 1992 | K915668 | BISCO CAVITY CLEANSER | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| April 29, 1991 | K910860 | ALL-BOND 2 | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| August 12, 1988 | K882915 | FORTIFY | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| March 10, 1988 | K875313 | PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| February 26, 1988 | K875256 | BISCOLOR | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| January 28, 1988 | K874557 | BISCO PORCELAIN REPAIR KIT | EBC | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| August 16, 1985 | K853001 | BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 28, 2008 | 47871 | Not yet classified | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Cement, Dental
- All makers of Material, Tooth Shade, Resin
- All makers of Agent, Tooth Bonding, Resin
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Varnish, Cavity
Updated July 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.