Manufacturer registered with FDA

Five Star Orthodontic Laboratory & Supply, Inc.

Denton, TX, United States. Lists 24 dental device types with FDA across 1 registered establishment.

FDA owner/operator10033551Contract manufacturerManufacturerRepacker / relabeler

Device types listed: 24
Brands and models: 204
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1United States

Devices listed with FDA

What Five Star Orthodontic Laboratory & Supply, 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 Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Lister	Fuji Ortho LCFuji Ortho SCLight Bondliquid etchPorcelain ConditionerRely-A-BondSelect DefenseSelf Cure Paste TipsTransbond LRTransbond XT	2013
Orthodontic WireDZC · Class 1	Orthodontic wires & bands	Maker	AlfAnterior Growth ApplianceAnterior Growth/Jet SagittalBi-Metric Distalizing ArchBilateral K-Loop DistalizerBluegrass ApplianceCantilever HerbstCD DistalizerControlled ArchCrozat - Lower 39 more Crozat - UpperCrozat (Fixed) - UpperCrozat (Fixed)- LowerDistal Jet ApplianceFixed Spring 3-Way (A) - UpperFixed Spring 3-Way (D) - UpperFrog ApplianceHerbst ApplianceHerbst Mini TelescopingHerbst Mini Telescoping ArmJet SagittalLingual E ArchLip Bumper ApplianceLower Fixed Crozat W/No BandsMagill SagittalMara ApplianceMolar RotatorMolar UprighterMyofunctional Tongue ThrustNickel Titanium ExpanderNiti Palatal ExpanderPendulum ApplianceQuad HelixRickonatorSliding Spring Space RegainerTandem Traction BowThree-Way ArnoldThumb Sucking ApplianceTongue Thrust ApplianceTransforce SagittalTransverse TransforceUnilateral K-Loop DistalizerVivos DNA ApplianceW-Arch ApplianceWilson 3D Lingual ArchWilson Multi-ActionWilson Multi-Action MandibularWilson Multi-Action PalatalWilson Omega Adjustable Stops	2013
Orthodontic Elastic BandECI · Class 1	Orthodontic wires & bands	Lister	—	2013
Orthodontic Metal BracketEJF · Class 1	Orthodontic brackets	Lister	—	2013
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Lister	Assure PlusAssure Universal Bonding ResinPrimerTransbond lollypopsTransbond MIPTransbond primer	2016
Anti-Snoring DeviceLRK · Class 2	Anti-snoring & jaw-repositioning devices	Maker	DreamTAPElastic Mandibular Advancement (EMA)mmRNATAP III Anti-Snoring DeviceVivos mRNA Appliance	2013
Orthodontic Extraoral HeadgearDZB · Class 2	Retainers, expanders & headgear	Lister	Face maskMulti-Adjustable Face MaskPedo reverse pull facemask	2016
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Lister	gel etchUltra Band Lok	2016
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Lister	LCRTriad Gel	2016
Orthodontic Screw Expansion RetainerDYJ · Class 1	Retainers, expanders & headgear	Maker	ActivatorAdult Split BionatorAnterior Sagittal w/ S BowAussie Wire 3X3Band & Loop Space RegainerBarrel Fixed Three-Way ApplianceBarrel SagittalBilateral Barrel DistalizerBilateral Leone DistalizerBioliner Plus - Lower 97 more Bioliner Plus - UpperBionatorBite Plane W/Two Clasps - LowerBite Plane W/Two Clasps - UpperBleaching Tray - LowerBleaching Tray - UpperBondable R.P.E. - No BandsBonded C.L.R.Bonded C.L.R. With TrayBonded RPEClass II FrankelCompact RPECrown & Loop Space MaintainerDistal Shoe Space MaintainerDual-Laminate Essix LowerDual-Laminate Essix UpperE-Regainer - LowerE-Regainer - UpperEssix Retainer - LowerEssix Retainer - UpperFive Star Bilateral Distalizer - LowerFive Star Bilateral Distalizer - UpperFive Star Fixed Expander - LowerFive Star Fixed Expander - UpperFive Star Mixed Dent Expander- LowerFive Star Mixed Dent Expander- UpperFive Star Unilateral Distalizer - LowerFive Star Unilateral Distalizer - UpperFixed Fan Gear ApplianceFS 3-Way w/Memory GearFS-3-Way-BarrelFS-3-Way-DistalizerFS-DistalizerFS-IPC-3-WayFS-SagittalGerber FinisherHaas ApplianceHan ApplianceHawley Spring Retainer - LowerHawley Spring Retainer - UpperHawley- LowerHawley- UpperJackson - LowerJackson - UpperMahoney Fixed 3-Way ApplianceMemory RPEMini BionatorModified Class III FrankelModified WilliamsN-SagittalNance ApplianceNord CrossbiteOrtho FinisherOrthopedic CorrectorPendexPost FinisherPre Bio-BlockRPESagittal - Lower W/GearSagittal - Upper W/GearSchwarz - Lower W/GearSchwarz - Upper W/GearSchwarz 3-Way - Upper W/GearSchwarz Fan-Gear - UpperSchwarz W/Duo-T Springs - LowerSchwarz/E-Regainer Combo-LowerSchwarz/E-Regainer Combo-UpperSchwarz/Sagittal Combo - LowerSchwarz/Sagittal Combo - UpperSelf-Activating Memory RPESingle Loop Space MaintainerSkeletal ExpanderSpahl Split Verticle ApplianceSpring Loaded Anterior Sagittal w/ LocksSpring Retainer 3X3 - LowerSpring Retainer 3X3 - UpperSpring Retainer 4X4 - LowerSpring Retainer 4X4 - UpperSpring-Loaded AlignerSuper Screw Fixed ExpanderTwin BlockUnilateral Barrel DistalizerUnilateral ExpanderWilliams - LowerWilliams - UpperWrap Around Hawley - LowerWrap Around Hawley - UpperZendura Clear Retainer - LowerZendura Clear Retainer - Upper3-Way Anterior Sagittal w/ S Bow3-Way Schwarz W/Duo-T Springs3X3 Banded Ling Ret W/Blank Ba3X3 Bonded Lingual W/2 Pads3X3 Bonded Lingual W/6 Pads3X3 Braided Lingual Retainer3X3 Spring W/Ball Clasps4X4 Bonded Lingual Retainer	2022
Orthodontic Material BandDYO · Class 1	Orthodontic wires & bands	Lister	—	2013
Orthodontic Space Preformed MaintainerDYT · Class 1	Retainers, expanders & headgear	Maker	Braided Lingual Retainer WireEZ Bond - LowerEZ Bond - UpperFLEA - LowerLingual Arch - LowerLingual Arch W/OmegaLower Lingual ArchRemovable Lingual ArchTPA/Nance ComboTransfer Tray 2 more Transpalatal ArchUpper Lingual Arch	2022
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Lister	Select Defense	2016
Resin Filling Material CoatingEBD · Class 2	—	Lister	Pro Seal	2017
Orthodontic Wire ClampECN · Class 1	—	Lister	—	2013
Orthodontic SpringECO · Class 1	Orthodontic wires & bands	Lister	—	2013
Intraoral Dental WaxEGD · Class 1	—	Lister	—	2013
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Lister	Porcelain Etch	2016
Orthodontic PlierJEX · Class 1	Dental hand instruments	Lister	Various Orthodontic Pliers	2017
Preformed Tooth PositionerKMY · Class 1	Retainers, expanders & headgear	Maker	Positioner	2022
Jaw Repositioning DeviceLQZ · Class 2	Anti-snoring & jaw-repositioning devices	Maker	mmRNA	2021
Orthodontic Ceramic BracketNJM · Class 2	Orthodontic brackets	Lister	—	2013
Sequential AlignerNXC · Class 2	Clear aligners	Maker	Tri-Aligner	2023
Indirect Bonding TrayQJJ · Class 1	—	Maker	Indirect Bond	2022

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

Also lists devices cleared under other names

Five Star Orthodontic Laboratory & Supply, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Reliance Orthodontic Products, Inc. (8), Bisco, Inc. (6), Ortho Organizers, Inc. (4), Glenroe Technologies (4), Ultimate Wireforms, Inc. (4), Classone Orthodontics, Inc. (2), GC America Inc. (2), Five Star Orthodontic Lab & Supply (1).

Decided	510(k)	Device	Applicant	Device type
19 Jun 2019	K182658	Bioliner	Five Star Orthodontic Lab & Supply	NXC Sequential Aligner
17 Nov 2011	K112118	DREAMBOND	Bisco, Inc.	KLE Resin Tooth Bonding Agent
19 May 2011	K110335	CERAMIC BRACKETS	Ortho Organizers, Inc.	NJM Orthodontic Ceramic Bracket
4 Feb 2010	K093059	SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT	Classone Orthodontics, Inc.	EBC Pit and Fissure Sealant and Conditioner
16 Jul 2008	K080445	LION SE ONE STEP ORTHODONTIC ADHESIVE	Classone Orthodontics, Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
7 Sep 2007	K071688	RELIANCE S.E.P.	Reliance Orthodontic Products, Inc.	KLE Resin Tooth Bonding Agent
15 Oct 2004	K041718	KELES FACEMASK	Great Lakes Orthodontics, Ltd.	DZB Orthodontic Extraoral Headgear
1 Aug 2002	K021503	UNINHIBITED	Bisco, Inc.	EBD Resin Filling Material Coating
7 Jul 2000	K001494	MODIFICATION TO PROMPT L-POP	Espe Dental AG	KLE Resin Tooth Bonding Agent
9 Jun 2000	K000358	MULTI ADJUSTABLE FACE MASK	Ortho Technology, Inc.	DZB Orthodontic Extraoral Headgear
27 Apr 2000	K001048	LIGHT BOND (QUICK CURE)	Reliance Orthodontic Products, Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
24 Feb 1998	K980053	GLENROE CHAIN	Glenroe Technologies	ECI Orthodontic Elastic Band
1 Dec 1997	K973495	GLENROE GLOW IN DARK ELASTOMERIC LIGATURES	Glenroe, LLC	ECI Orthodontic Elastic Band
10 Jul 1996	K961754	SAFETY RELEASE MODULE	G&H Wire Company	DZB Orthodontic Extraoral Headgear
24 May 1996	K961417	GC FUJI ORTHO	GC America Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
8 Mar 1995	K950556	FUJI ORTHO LC	GC America Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
27 Jan 1995	K945535	GLENROE ORTHO-SIL	Glenroe Technologies	EGD Intraoral Dental Wax
3 Jan 1995	K945604	ECLIPTOMER	Bisco, Inc.	KLE Resin Tooth Bonding Agent
13 Sep 1993	K923218	NITANIUM PALATAL EXPANDER	Ortho Organizers, Inc.	EJF Orthodontic Metal Bracket
1 Sep 1993	K931980	STAINLESS STEEL ORTHODONTIC PRODUCTS	Ortho Organizers, Inc.	DYO Orthodontic Material Band
22 Jul 1993	K931462	GLENROE CHAIN	Glenroe Technologies	ECI Orthodontic Elastic Band
8 Jul 1993	K931663	NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL	Ortho Organizers, Inc.	EJF Orthodontic Metal Bracket
8 Apr 1993	K924139	GLENROE ORTHO SEPS	Glenroe Technologies	ECI Orthodontic Elastic Band
31 Mar 1993	K926238	BISCO PORCELAIN ETCHING GEL	Bisco, Inc.	EIH Porcelain Powder
31 Mar 1993	K923837	DIMPLED MULTI MODULUS ARCH WIRE	Ultimate Wireforms, Inc.	DZC Orthodontic Wire
31 Mar 1993	K924805	ORTHODONTIC ARCH WIRE	Ultimate Wireforms, Inc.	DZC Orthodontic Wire
28 Dec 1992	K924151	BISCO D/C RESINOMER	Bisco, Inc.	EBF Resin Tooth Shade Material
4 Dec 1992	K923838	THE ULTIMATE RCS ARCH WIRE	Ultimate Wireforms, Inc.	DZC Orthodontic Wire
15 Oct 1992	K923839	NITINOL GENTLE TOUCH COIL SPRING	Ultimate Wireforms, Inc.	DZC Orthodontic Wire
13 Aug 1990	K902390	AURA CERAMIC DENTAL APPLIANCE	Progressive Technology, Inc.	EJF Orthodontic Metal Bracket
7 Dec 1989	K895521	RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)	Reliance Orthodontic Products, Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
7 Dec 1989	K895522	LIGHT BOND PASTE W/FLUORIDE	Reliance Orthodontic Products, Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
17 Oct 1989	K894564	RELIANCE LIGHT CURE RETAINER ACRYLIC	Reliance Orthodontic Products, Inc.	EBI Rebasing Repairing Relining Denture Resin
12 Aug 1988	K882482	TRIAD ORTHODONTIC GEL	Dentsply Intl., Inc.	EBI Rebasing Repairing Relining Denture Resin
13 Jun 1988	K880793	LIGHT BOND	Reliance Orthodontic Products, Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
18 Apr 1988	K880790	PORCELAIN PRIMER	Reliance Orthodontic Products, Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive
31 Mar 1988	K880393	TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE	Unitek Corp.	DYH Resin Bracket and Tooth Conditioner Adhesive
10 Mar 1988	K875313	PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST	Bisco, Inc.	EBF Resin Tooth Shade Material
26 Feb 1988	K875143	RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)	Reliance Orthodontic Products, Inc.	DYH Resin Bracket and Tooth Conditioner Adhesive

Registered establishments

Establishment	Location	What it does
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.FDA reg. 1000118628	Denton, TX, United States	Contract manufacturer, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10033551). 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.