Manufacturer registered with FDA

Bisco, Inc.

Schaumburg, IL, United States. Lists 15 dental device types with FDA across 1 registered establishment, and holds 88 510(k) clearances as applicant.

FDA owner/operator1420052Contract manufacturerManufacturerRepacker / relabelerSpecification developer2 clearances in five years

Device types listed: 15
Brands and models: 94
510(k) clearances: 881984–2025
Markets registered in: 14670 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 1980–2026

Registered in 14 markets

Where regulators' registries name Bisco, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Bisco, Inc.	88 clearances	1984–2025	Below
Canada	Health Canada	Registration holder	BISCO, INC.	175	2001–2026	Pure Global AI
Colombia	INVIMA	Registration holder	BISCO, INCBISCO, INC.	159	—	Pure Global AI
South Korea	MFDS	Manufacturer	Bisco,Inc.Bisco, Inc · Bisco, Inc. · +2	126	1998–2026	Pure Global AI
Taiwan	TFDA	Manufacturer	BISCO, INC.	43	2005–2026	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	Bisco,IncBISCO, INC · BISCO INC	39	—	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Bisco, Inc	39	—	Pure Global AI
Peru	DIGEMID	Manufacturer	BISCO, INCBISCO INC	25	2010–2026	Pure Global AI
Brazil	ANVISA	Manufacturer	BISCO INCBISCO INC.	20	2007–2018	Pure Global AI
China	NMPA	Registration holder	必思科公司BISCO, INC.必思科公司Bisco, Inc. · 必思科公司Bisco, Incorporated · +2	13	—	Pure Global AI
United Kingdom	MHRA	Manufacturer	Bisco, Inc.	13	—	Pure Global AI
Australia	TGA	Manufacturer	Bisco Inc	7	2004–2018	Pure Global AI
Egypt	EDA	Manufacturer	BISCO, INC,	6	2025–2026	Pure Global AI
Israel	AMAR	Manufacturer	Bisco, Inc.BISCO INC	5	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Bisco, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	AELITE AESTHETIC ENAMELAELITE ALL-PURPOSE BODYAELITE LS PACKABLE DENTINAELITE LS PACKABLE ENAMELAELITE LS POSTERIORAELITEFLOCAVITY CLEANSERCHARACTERIZATION TINTCHOICECHOICE 2 19 more Choice 2 Try-in-PasteCORE-FLO DCCore-Flo DC LiteeCement (Light-Cured Resin Cement)eCEMENT Try-In-PasteFORTIFYLIGHT COREPORCELAIN BONDING RESINQuantiumTESCERA BODYTESCERA CHROMATESCERA COLOR MODIFIERTESCERA DENTINTESCERA ENAMELTESCERA FLOTESCERA INCISALTESCERA OPAQUER POWDERTESCERA OPAQUER/SCULPTING RESINTESCERA ROOT DENTIN	2007
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	ALL-BOND 2ALL-BOND 3ALL-BOND 3 RESINALL-BOND UNIVERSALAll-Bond Universal w/BACAQUA-PREP FBISFIL 2BD/E RESINETCH-37ETCH-37 with BAC 7 more PRE-BONDSELECT HV ETCHSELECT HV ETCH with BACUNI-ETCHUNI-ETCH with BACUniversal PrimerZ-PRIME PLUS	2007
Dental CementEMA · Class 2	Dental cements	Maker	BISCEMChoice 2 DCDUO-LINKDUO-LINK UNIVERSALeCement (Dual-Cured Resin Cement)ONE-STEPONE-STEP PLUSTheraBaseTheraBase CaTheraCem 2 more TheraCem CaZ-CEM SA	2007
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Maker	LIQUID ETCHANTORTHO-ONE	2012
Resin Filling Material CoatingEBD · Class 2	—	Maker	MODELING RESIN	2007
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Maker	THERACAL LCTheraCal PT	2011
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	BIS-SILANEOPAQUER D/CPORCELAIN PRIMER	2007
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Maker	—	2012
Intraoral Dental WaxEGD · Class 1	—	Maker	—	2023
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	AELITEFLO ANGLED TIPSAELITEFLO LV TIPSAuto-Mix Cannula TipsBLUE TIPDUAL-SYRINGE DISPENSERDUAL-SYRINGE INTRA-ORAL MIXING TIPSDUAL-SYRINGE ROOT CANAL MIXING TIPSDUAL-SYRINGE STATIC MIXING TIPEtch-37 AccessoriesFlowable Syringe Tips 6 more L/V TIP/PLUGNEEDLE BRUSH TIPSNEEDLE TIP/PLUGSELECT HV ETCH ACCESSORIESUni-Etch AccessoriesUNIT-DOSE DISPENSING SYRINGE	2011
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Maker	BARRIER GELPORCELAIN ETCHANT 4%PORCELAIN ETCHANT 9.5%	2007
Resin ApplicatorKXR · Class 1	—	Lister	BISCO APPLICATORSBISCO BRISTLE APPLICATORBRUSH TIPSDISPOSABLE MIXING WELLSDISPOSABLE SPATULASHANDLESMIXING PADRESINVOIR MIXING WELL	2011
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	—	2014
Sequential AlignerNXC · Class 2	Clear aligners	Maker	—	2013
External Cleaning SolutionPME · Class 2	—	Maker	ZirClean	2017

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Bisco, Inc. as the applicant.

Decided	510(k)	Device	Device type
11 Jul 2025	K250156	Choice 2 DC	EMA Dental Cement
17 Dec 2024	K242816	Quantium	EBF Resin Tooth Shade Material
17 Mar 2020	K192007	TheraBase, TheraBase Ca	EMA Dental Cement
18 Nov 2019	K182917	FluoroCal	LBH Cavity Varnish
5 Apr 2018	K180344	TheraCal DC	EJK Calcium Hydroxide Cavity Liner
4 Aug 2017	K171147	REVEAL Bulk	EBF Resin Tooth Shade Material
23 May 2017	K162598	HAPI Seal	EBC Pit and Fissure Sealant and Conditioner
14 Apr 2017	K163171	CeraClean	PME External Cleaning Solution
9 Sep 2016	K161051	All-Bond Universal w/BAC (not finalized)	KLE Resin Tooth Bonding Agent
29 Jul 2016	K161256	TheraCem	EMA Dental Cement
4 Aug 2015	K143292	TheraCal DC	EJK Calcium Hydroxide Cavity Liner
12 Sep 2014	K141439	ORTHODONTIC ACRYLIC (NOT FINALIZED)	EBI Rebasing Repairing Relining Denture Resin
11 Apr 2014	K131734	ALL-BOND UNIVERSAL SC (NOT FINALIZED)	KLE Resin Tooth Bonding Agent
3 Jun 2013	K123653	SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)	LBH Cavity Varnish
7 Feb 2012	K113401	ORTHO-1(NOT FINALIZED)	DYH Resin Bracket and Tooth Conditioner Adhesive
17 Nov 2011	K112118	DREAMBOND	KLE Resin Tooth Bonding Agent
25 May 2011	K103514	PRO-V COAT	EBG Resin Temporary Crown and Bridge
29 Oct 2010	K102844	ALL-BOUND 3	KLE Resin Tooth Bonding Agent
8 Oct 2010	K101787	DUOLINK II	EMA Dental Cement
26 Aug 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 Resin Tooth Bonding Agent
17 Feb 2010	K093470	CORE-FLO D/C	EBF Resin Tooth Shade Material
28 Aug 2009	K091705	PRIMER PLUS	KLE Resin Tooth Bonding Agent
25 Sep 2008	K082449	BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012	EMA Dental Cement
14 Feb 2008	K073263	PRO-V	EBG Resin Temporary Crown and Bridge
19 Jan 2007	K063780	ACE BOND SE	KLE Resin Tooth Bonding Agent
8 Dec 2006	K063237	THERACAL LC	EJK Calcium Hydroxide Cavity Liner
15 May 2006	K060701	BISCEM TRANSLUCENT, BISCEM OPAQUE	EMA Dental Cement
29 Mar 2006	K052122	BISCO LED	EBZ Ultraviolet Activator for Polymerization
22 Aug 2005	K051999	BISCOVER LED	EBD Resin Filling Material Coating
20 Apr 2005	K050647	ALL-IN-ONE	KLE Resin Tooth Bonding Agent
1 Feb 2005	K043168	BISCOVER LV	EBD Resin Filling Material Coating
1 Feb 2005	K042804	TESCERA OPAQUER POWDER/SCULPTING RESIN	EBF Resin Tooth Shade Material
19 Mar 2004	K034024	TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS	EBI Rebasing Repairing Relining Denture Resin
16 Jan 2004	K033585	DIAPEX	KIF Root Canal Filling Resin
16 Jan 2004	K033521	BISBLOCK	EJK Calcium Hydroxide Cavity Liner
15 Jan 2004	K033472	TESCERA U-BAR AND BARRELS	EBI Rebasing Repairing Relining Denture Resin
4 Nov 2003	K032597	BISCEM GI	EMA Dental Cement
6 Jun 2003	K030951	TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P	EBF Resin Tooth Shade Material
28 Apr 2003	K030585	SCULPTING RESIN	EBD Resin Filling Material Coating
19 Feb 2003	K030354	BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER	EBD Resin Filling Material Coating
6 Feb 2003	K024046	TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P	EBD Resin Filling Material Coating
1 Aug 2002	K021503	UNINHIBITED	EBD Resin Filling Material Coating
17 Jan 2002	K013519	SIMPLE	KLE Resin Tooth Bonding Agent
17 Sep 2001	K012032	FIRST SPEP	DYH Resin Bracket and Tooth Conditioner Adhesive
5 Sep 2001	K012180	A-WEAR	EBF Resin Tooth Shade Material
8 Jun 2001	K011159	ONE-STEP PLUS	EMA Dental Cement
5 Apr 2001	K010196	TOTAL CURE	EBF Resin Tooth Shade Material
28 Nov 2000	K003361	RENEW LS-2	EBF Resin Tooth Shade Material
21 Nov 2000	K003317	RENEW LS-1	EBF Resin Tooth Shade Material
12 Apr 2000	K000426	VIP- VARIABLE INTENSITY POLYMERIZER	EBZ Ultraviolet Activator for Polymerization
10 Nov 1999	K993488	LIGHT-CORE	EBF Resin Tooth Shade Material
27 Oct 1999	K993192	ILLUSION	EBF Resin Tooth Shade Material
25 Aug 1999	K992248	POST CEMENT HI-X	EBF Resin Tooth Shade Material
22 Dec 1998	K984112	ADVENT	EBF Resin Tooth Shade Material
15 Sep 1998	K982729	RENEW	EBF Resin Tooth Shade Material
2 Sep 1998	K982645	PYRAMID	EBF Resin Tooth Shade Material
9 Feb 1998	K974483	NTL-FLOW	EBF Resin Tooth Shade Material
1 Jul 1997	K970484	ACCU-PREP	KOJ Airbrush
10 Feb 1997	K964931	WHITE CORE	EBF Resin Tooth Shade Material
5 Nov 1996	K964000	BISFIL 2B	KLE Resin Tooth Bonding Agent
3 Sep 1996	K962946	ORTHO-ONE	DYH Resin Bracket and Tooth Conditioner Adhesive
11 Jun 1996	K961822	WET-PREP	KLE Resin Tooth Bonding Agent
13 Dec 1995	K955292	AELITEFLO	EBF Resin Tooth Shade Material
31 Mar 1995	K945370	C-POST	ELR Root Canal Post
3 Jan 1995	K945604	ECLIPTOMER	KLE Resin Tooth Bonding Agent
4 Feb 1994	K940030	BISCO COMPOSITE	EMA Dental Cement
26 Jan 1994	K934596	BISCO DUO LINK D/C LUTING COMPOSITE	KLE Resin Tooth Bonding Agent
29 Nov 1993	K934247	BISCO UNIVERSAL HYBRID COMPOSITE	EBF Resin Tooth Shade Material
24 Aug 1993	K930405	BISCO D/C CORE COMPOSITE	EBF Resin Tooth Shade Material
22 Jul 1993	K932379	ALL-BOND(R) JR.	KLE Resin Tooth Bonding Agent
31 Mar 1993	K926238	BISCO PORCELAIN ETCHING GEL	EIH Porcelain Powder
28 Dec 1992	K924151	BISCO D/C RESINOMER	EBF Resin Tooth Shade Material
29 Sep 1992	K923842	BISCO UNIVERSAL BOND-3	KLE Resin Tooth Bonding Agent
11 May 1992	K921439	BISCO CORE PASTE	EBF Resin Tooth Shade Material
21 Apr 1992	K915668	BISCO CAVITY CLEANSER	EBF Resin Tooth Shade Material
29 Apr 1991	K910860	ALL-BOND 2	KLE Resin Tooth Bonding Agent
29 Mar 1991	K910628	ALL BOND LINER-F	KLE Resin Tooth Bonding Agent
14 Mar 1990	K897020	ALL-BOND DENTIN BONDING SYSTEM	KLE Resin Tooth Bonding Agent
12 Oct 1988	K883465	ORTHO-SEAL	DYH Resin Bracket and Tooth Conditioner Adhesive
12 Aug 1988	K882915	FORTIFY	EBF Resin Tooth Shade Material
10 Mar 1988	K875313	PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST	EBF Resin Tooth Shade Material
26 Feb 1988	K875256	BISCOLOR	EBF Resin Tooth Shade Material
28 Jan 1988	K874557	BISCO PORCELAIN REPAIR KIT	EBC Pit and Fissure Sealant and Conditioner
28 Jan 1988	K874556	BISCO PIT AND FISSURE SEALANT	EBC Pit and Fissure Sealant and Conditioner
30 Apr 1986	K861148	BISCO'S PORCELAIN VENEER SYSTEM	EBF Resin Tooth Shade Material
16 Aug 1985	K853002	BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)	EBF Resin Tooth Shade Material
16 Aug 1985	K853001	BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)	EBF Resin Tooth Shade Material
12 Jul 1984	K842087	BISFIL-I LIGHT CURABLE POSTERIOR COMPO	EBF Resin Tooth Shade Material

Some of these clearances are listed with FDA today by another company: Reliance Orthodontic Products, Inc. (12), Five Star Orthodontic Laboratory & Supply, Inc. (6), Xplora USA LLC (1), Ortho Solutions LC (1).

Registered establishments

Establishment	Location	What it does
BISCO, INC.FDA reg. 1420052	Schaumburg, IL, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1420052). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.