Manufacturer registered with FDA

Ultradent Products, Inc.

South Jordan, UT, United States. Lists 42 dental device types with FDA across 1 registered establishment, and holds 95 510(k) clearances as applicant.

FDA owner/operator1718962Contract manufacturerManufacturerRepacker / relabeler6 clearances in five years

Device types listed: 42
Brands and models: 235
510(k) clearances: 951992–2026
Markets registered in: 163,101 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 1990–2026

Registered in 16 markets

Where regulators' registries name Ultradent Products, 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	Ultradent Products, Inc.	95 clearances	1992–2026	Below
Colombia	INVIMA	Registration holder	ULTRADENT PRODUCTS INCULTRADENT PRODUCTS INC., · ULTRADENT PRODUCTS INC.	2,342	—	Pure Global AI
South Korea	MFDS	Manufacturer	Ultradent Products, Inc.ULTRADENT PRODUCTS, INC. · ULTRADENT PRODUCTS, INC · +2	194	1998–2026	Pure Global AI
Canada	Health Canada	Registration holder	ULTRADENT PRODUCTS, INC.	158	1999–2025	Pure Global AI
European Union	EUDAMED	Registration holder	Ultradent Products, Inc.	90	—	Pure Global AI
Taiwan	TFDA	Manufacturer	ULTRADENT PRODUCTS, INC.Ultradent Products, Inc.	77	2004–2026	Pure Global AI
Australia	TGA	Manufacturer	Ultradent Products Inc	50	2003–2024	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	ULTRADENT PRODUCTS. INC.Ultradent Products, Inc.	49	—	Pure Global AI
Brazil	ANVISA	Manufacturer	ULTRADENT PRODUCTS INCULTRADENT PRODUCTS INC.	44	2006–2026	Pure Global AI
United Kingdom	MHRA	Manufacturer	Ultradent Products Inc	32	—	Pure Global AI
China	NMPA	Registration holder	美国皓齿制品有限公司Ultradent Products, Inc.美国皓齿制品有限公司Ultradent Products Inc. · 美国皓齿制品有限公司Ultradent Products,Inc.	29	—	Pure Global AI
Peru	DIGEMID	Manufacturer	ULTRADENT PRODUCTS, INCULTRADENT PRODUCTS INC · ULTRADENT PRODUCTS, Inc · +2	23	2021–2025	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Ultradent products Inc	5	—	Pure Global AI
Japan	PMDA	Registration holder	ＵＬＴＲＡＤＥＮＴ　ＰＲＯＤＵＣＴＳ，　ＩＮＣ．	4	2008–2008	Pure Global AI
Israel	AMAR	Manufacturer	Ultradent Products, Inc.	3	—	Pure Global AI
Hong Kong	MDD	Manufacturer	Ultradent Products Inc.	1	2025–2025	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 Ultradent Products, 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	Amelogen PlusComposite Wetting ResinForma SJ-TempMosaic Universal CompositeOpal EtchPermaFloPermaFlo PinkPermaFlo PurplePermaSeal 8 more SilaneTranscendTranscend Flowable Bulk Fill Refill Universal SyringesUltra-EtchUltradent Diamond Polish MintUltraSeal XT hydro bioprotection by NobioUltraSeal XT plus bioprotection by NobioVit-l-escence	2007
Impression MaterialELW · Class 2	Impression materials	Maker	Chromaclone 5 Day StabilityChromaclone Ortho 5 Day StabilityChromaclone PuttyChromaclone PVS (Fast Set)Chromaclone PVS (Reg. Set)Chromaclone PVS PuttyClone BiteLumalocThermo Clone VPS Alginate Alternative 10x50 ml Bulk PackThermo Clone VPS Alginate Alternative 2x50 ml Kit 6 more Thermo Clone VPS Clear Bite Registration Fast SetThermo Clone VPS Fast Alginate Alternative 380 ml KitThermo Clone VPS Fast Set Bite RegistrationThermo Clone VPS Fast Set Superlight BodyThermo Clone VPS Medium Body and Fast Set Medium Body & Heavy Body and Fast Set Heavy BodyThermo Clone VPS Putty Fast Set	2007
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Maker	Opal Band CementOpal BondOpal Bond FlowOpal Bond MVOpal SealTranscend Flowable Bulk Fill Refill Universal SyringesUltraCEM Resin Reinforced Glass Lonomer Luting Cement	2007
Dental CementEMA · Class 2	Dental cements	Maker	Clear TempDeOxPermaShade LC Light Cure Veneer CementPermaShade Try-In PasteUltraCEM Resin Reinforced Glass Lonomer Luting CementUltraTempUltraTemp REZ II	2007
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	ConsepsisConsepsis ScrubConsepsis VConsumer Opalescence Sensitivity ReliefEnamelastGleo VarnishUltraEZUniversal Dentin Sealant	2007
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Maker	VALOVALO Accessory (16' cord Power Supply)VALO Black Light Lens, VALO Grand Black Light LensValo Corded Accessory (light shield, lenses, blocking glassses, bracket holder, charging unit power supply etc.VALO CordlessVALO Cordless Accessory(Battery Charger,Rechargeable Batteries,Light Shield,Bracket Holder,Charging Unit Power Supply)VALO GrandValo Grand Accessory(battery charger,rechargeable batteries,light shield,bracket holder,charging unit power supply,etc.)VALO Grand CordedVALO Grand White Light Lens 18 more VALO Interproximal Lens, VALO Grand Interproximal LensVALO ORTHOVALO Ortho CordlessVALO PointCure Lens, VALO Grand PointCure LensVALO ProxiCure Ball Lens, VALO Grand ProxiCure Ball LensVALO TransLume Lens, VALO Grand TransLume LensVALO XVALO X Accessories (Assembled Cord, Power Supply, Battery Charger, Batteries)VALO X Accessory Lenses (PointCure Lens, ProxiCure Ball Lens, Diffuser Lens, Interproximal Lens, TransLume Lens)VALO X Color LoanersVALO X ColorsVALO X Demo Unit ColorsVALO XG Color LoanersVALO XG ColorsVALO XG Demo Unit ColorsVALO XS Color LoanersVALO XS ColorsVALO XS Demo Unit Colors	2009
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	EndoREZ AcceleratorEndoREZ Dual CureEndoREZ Obturation KitMTApex Bioceramic Root Canal SealerUltraCal XS	2007
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	Peak SEPeak Universal BondPeak-ZMPermaFlo DCPQ1	2007
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	PrimaDryUltraSeal XT hydroUltraSeal XT hydro bioprotection by NobioUltraSeal XT PlusUltraSeal XT plus bioprotection by Nobio	2007
Ultraviolet DetectorEAQ · Class 2	—	Maker	VALO Black Light Lens, VALO Grand Black Light LensVALO Grand White Light LensVALO Interproximal Lens, VALO Grand Interproximal LensVALO PointCure Lens, VALO Grand PointCure LensVALO ProxiCure Ball Lens, VALO Grand ProxiCure Ball LensVALO TransLume Lens, VALO Grand TransLume LensVALO XVALO X Accessories (Assembled Cord, Power Supply, Battery Charger, Batteries)VALO X Accessory Lenses (PointCure Lens, ProxiCure Ball Lens, Diffuser Lens, Interproximal Lens, TransLume Lens)VALO X Color Loaners 8 more VALO X ColorsVALO X Demo Unit ColorsVALO XG Color LoanersVALO XG ColorsVALO XG Demo Unit ColorsVALO XS Color LoanersVALO XS ColorsVALO XS Demo Unit Colors	2021
All Types RetractorEIG · Class 1	Dental hand instruments	Maker	IsoBlockOpalDamOpalDam GreenOT Gingival BarrierPropGuardSof-Tray Classic SheetsUmbrella Cheek Retractor	1999
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Maker	UltraBlend PlusUltraCal XS	2007
Orthodontic Plastic BracketDYW · Class 2	Orthodontic brackets	Maker	Opal Bond	2007
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	Enamelast Application BrushesExperTemp Dispensing GunImpression Dispensing GunINTERGUARDMicro ApplicatorsQuad KeyUltradent Composite GunUltradent Micro Applicators	1999
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Lister	ExperTemp	2013
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Maker	EmilumaULTRADENT LC BLOCK-OUT RESIN	2007
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Lister	Ultrapro Tx Air Hygiene HandpieceUltrapro TX Air Motor and Nose Cones	2008
Intraoral Dental WaxEGD · Class 1	—	Maker	Gishy Goo	2007
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Lister	JIFFY CUPSJIFFY DISKSJiffy HiShine CupsJiffy HiShine DisksJIFFY POINTSJiffy Polishing Cups (F, M, C)Jiffy Polishing Disks (F, M, C)	1995
Prophylaxis CupEHK · Class 1	Polishing & prophylaxis	Lister	Opal Cups, BristleOpal Cups, Finishing	1995
Abrasive PointEHL · Class 1	Polishing & prophylaxis	Lister	Jiffy Natural Composite Polishing KitJiffy Natural Universal Intra-Oral Polishing KitJiffy Universal Adjusting & Polishing Kits	1995
Polishing Agent StripEHM · Class 1	Polishing & prophylaxis	Lister	JIffy Diamond StripsJIFFY PROXIMAL SAW-FINISH	2007
Oral Cavity EvacuatorEHZ · Class 1	Suction & evacuation units	Maker	Ultradent Luer Vacuum Adapter	2007
Irrigating Endodontic Periodontic SyringeEIC · Class 1	Dental hand instruments	Maker	Capillary TipsDeliver-Eze Irrig. & Evac. KitEndo-Eze Irrig. TipsEndo-Eze TipsHemostatic Delivery SyringesMicro 20g tipsMicro Capillary TipsNaviTipNaviTip FX TipsSkini Syringes 5 more SST Surgical Suction TipTriAway AdaptorUltradent Syringe Covers1.2 mL Plastic Syringe5 mL Plastic Syringe	1994
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	Black Micro TipsBlack Mini TipsBlue Micro TipsBlue Mini TipsChromaclone PVS Mixing TipsDento-Infusor TipsExpertemp Mixing TipsIntraOral Impression TipsIntraOral TipLuer Lock Caps 9 more Metal Dento-Infusor Tip with Comfort HubMicro 20g FX TipsMixing TipsOpal Band Mixing TipsOpal Bond Flow TipThermo Clone VPS Dynamic MixerWhite Mac TipsWhite Mini Tips3 mL Impression Syringe	1994
Rubber DamEIE · Class 1	Rubber dam systems	Maker	OralSeal KitOralSeal PuttyOraSeal Caulking	1995
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Maker	EtchArrestPorcelain EtchUltradent Porcelain Repair Kit	2007
Dental Plastic Filling InstrumentEIY · Class 1	Dental hand instruments	Maker	Black Micro FX TipsSoftEZ Tips	1996
Dental Instrument HandleEJB · Class 1	Dental hand instruments	Lister	Fischer's Ultrapak PackerHalo Sectional Matrix ForcepsHalo Sectional Matrix TweezersUltradent Slide Packer	1994
Dental BurEJL · Class 1	Dental burs & diamonds	Maker	Ultradent Comp. Finishing Bur KitUnicore Drill	1994
Polishing Agent WheelEJQ · Class 1	Polishing & prophylaxis	Maker	Jiffy Composite Pol. Brush (ptd)Jiffy Composite Pol. Brush (reg)Jiffy Goat Hair BrushStarBrush	1999
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Maker	OPALUSTREUltrapro Tx Prophy Paste	1998
Operative BurnisherEKJ · Class 1	Dental hand instruments	Lister	SYRINGE COVERS	1995
Gutta-PerchaEKM · Class 1	Root canal filling materials	Maker	Endo-Eze Genius Gutta PerchaEndoREZ Points	2007
Ac-Powered Direct Drive HandpieceEKX · Class 1	Dental handpieces	Lister	Ultrapro Tx Cordless Prophy Motor Kit	2023
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Maker	Ultrawave Bottle cap	2014
Root Canal PostELR · Class 1	Root canal filling materials	Lister	UniCore Accessory PostsUniCore Post	1996
Matrix RetainerJEP · Class 1	Dental hand instruments	Maker	Halo Sectional Matrix BandsHalo Sectional Matrix RingHalo Sectional Matrix WedgesHalo Sectional Non-Stick Matrix BandsOmni-Matrix Original WingedOmni-Matrix Original WinglessOmni-Matrix SectionalOmni-Matrix WingedOmni-Matrix Wingless	1999
Dental FlossJES · Class 1	Floss & interdental cleaners	Maker	UltraPakUltraPak Kit	2013
Massaging PickJET · Class 1	Floss & interdental cleaners	Maker	OPAL PIX	2007
Resin ApplicatorKXR · Class 1	—	Maker	Black Mini Brush TipsInspiral Brush TipsOpal Red TipsOpal Seal Tips	1994
Caries Detection DeviceLFC · Class 2	Caries detection devices	Maker	Sable SeekSeek	2007

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 Ultradent Products, Inc. as the applicant.

Decided	510(k)	Device	Device type
1 Jul 2026	K262228	Transcend Bulk Fill Flowable Composite	EBF Resin Tooth Shade Material
30 Apr 2026	K261404	UltraEZ	LBH Cavity Varnish
20 Mar 2024	K240743	Peak Universal Bond	KLE Resin Tooth Bonding Agent
15 Mar 2024	K240694	FORMA Composite (Shade A3D)	EBF Resin Tooth Shade Material
1 Jul 2022	K221909	J-Temp	EBF Resin Tooth Shade Material
22 Feb 2022	K220471	VALO X, VALO X Accessory Lenses	EBZ Ultraviolet Activator for Polymerization
13 Oct 2021	K211905	UltraCal XS	KIF Root Canal Filling Resin
13 Jul 2021	K211237	UltraTemp Rez II	EMA Dental Cement
1 Mar 2021	K210550	VALO Grand Corded and Accessory Lenses	EBZ Ultraviolet Activator for Polymerization
29 Apr 2019	K190627	VALO Grand Corded	EBZ Ultraviolet Activator for Polymerization
13 Jul 2016	K160551	VALO Grand	EBZ Ultraviolet Activator for Polymerization
21 Jul 2015	K151094	Mosaic Universal Composite	EBF Resin Tooth Shade Material
6 Sep 2013	K131357	PEAK Z	KLE Resin Tooth Bonding Agent
23 Sep 2011	K112517	ULTRASEAL XT HYDRO	EBC Pit and Fissure Sealant and Conditioner
16 Sep 2011	K111836	PERMASHADE VENEER CEMENT	EMA Dental Cement
7 Sep 2011	K111696	OPAL BAND CEMENT	DYH Resin Bracket and Tooth Conditioner Adhesive
6 Jun 2011	K111017	CLEARTEMP	EMA Dental Cement
28 Apr 2011	K110582	VALO CORDLESS	EBZ Ultraviolet Activator for Polymerization
17 Sep 2010	K101245	ULTRASEAL ID	EBC Pit and Fissure Sealant and Conditioner
16 Jul 2010	K100752	PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)	KLE Resin Tooth Bonding Agent
29 Apr 2010	K100301	OPAL BOND FLOW	DYH Resin Bracket and Tooth Conditioner Adhesive
23 Mar 2010	K094006	OPAL BOND MV	DYH Resin Bracket and Tooth Conditioner Adhesive
29 Apr 2009	K090355	OPAL SEAL	DYH Resin Bracket and Tooth Conditioner Adhesive
23 Jan 2009	K083647	VALO, MODEL 5919	EBZ Ultraviolet Activator for Polymerization
11 Apr 2008	K080768	ULTRATEMP FIRM, FAST AND REGULAR SET	EMA Dental Cement
8 Feb 2008	K080249	FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505	LBH Cavity Varnish
12 Jun 2007	K061438	ULTRAEZ DESENSITIZING GEL	LBH Cavity Varnish
8 May 2007	K071106	ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399	KIF Root Canal Filling Resin
3 May 2007	K071055	OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802	DYW Orthodontic Plastic Bracket
14 Dec 2006	K063558	PEAK SE, MODEL 5135	KLE Resin Tooth Bonding Agent
12 Dec 2006	K063557	PEAK BOND, MODEL 5133	KLE Resin Tooth Bonding Agent
23 Feb 2006	K060334	GI DENTSTAT	EMA Dental Cement
19 Sep 2005	K051750	FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502	LBH Cavity Varnish
19 Jul 2005	K042583	CALC-I-OSS	LYC Synthetic Bone Grafting Material
31 Mar 2005	K050730	MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM	DYW Orthodontic Plastic Bracket
17 Dec 2004	K043119	AMELOGEN PLUS	EBF Resin Tooth Shade Material
26 Oct 2004	K042756	ENDOREZ	KIF Root Canal Filling Resin
26 Feb 2004	K032625	ORTHODONTIC COMPOSITE BRACKET SYSTEM	DYW Orthodontic Plastic Bracket
3 Dec 2003	K032626	PERMAQUICK SE BONDING SYSTEM	KLE Resin Tooth Bonding Agent
28 Oct 2002	K023042	PQ1	KLE Resin Tooth Bonding Agent
6 Feb 2001	K003383	PALMLIGHT	EBZ Ultraviolet Activator for Polymerization
11 May 2000	K000189	PQ1	KLE Resin Tooth Bonding Agent
16 Feb 2000	K993846	ULTRASEAL XT PLUS	EBC Pit and Fissure Sealant and Conditioner
2 Feb 2000	K994261	ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT	EMA Dental Cement
26 Oct 1999	K992097	ENDOREZ	KIF Root Canal Filling Resin
13 Oct 1999	K992380	ENDO-EZE MOTOR AND HANDPIECE	EFB Dental Air-Powered Handpiece
30 Nov 1998	K983668	MODIFICATION OF PQ1	KLE Resin Tooth Bonding Agent
12 May 1998	K980726	ULTRA-BLASTER	KOJ Airbrush
3 Mar 1998	K974786	PREPQUICK	KLE Resin Tooth Bonding Agent
2 Feb 1998	K974413	PERMAFLO	EBF Resin Tooth Shade Material
29 Jan 1998	K974283	PQ 1	KLE Resin Tooth Bonding Agent
29 Jan 1998	K974282	VITALESCENCE	EBF Resin Tooth Shade Material
26 Jun 1997	K971899	ENDO-SEAL	KIF Root Canal Filling Resin
24 Jun 1997	K971898	PERMALUTE, TRY-IN PASTE	EBF Resin Tooth Shade Material
3 Jun 1997	K971284	OPALDAM	EIG All Types Retractor
2 Apr 1997	K970113	ULTRA-BLEND PLUS	EJK Calcium Hydroxide Cavity Liner
14 Mar 1997	K970114	ULTRACAL XS	EJK Calcium Hydroxide Cavity Liner
26 Feb 1997	K964808	SPETEMP	EMA Dental Cement
10 Feb 1997	K964810	DERMADAM	EFS Oral Irrigation Unit
31 Jan 1997	K965060	ULTRA-ETCH STAT	EBF Resin Tooth Shade Material
2 Jan 1997	K964809	SPETEMP EF	EMA Dental Cement
12 Dec 1996	K963979	ULTRADENT UNIVERSAL DENTIN SEALANT	LBH Cavity Varnish
18 Jul 1996	K960696	PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM	KLE Resin Tooth Bonding Agent
6 May 1996	K960697	ULTRACID AND ULTRACID F DISINFECTING SOLUTION	KLE Resin Tooth Bonding Agent
8 Sep 1995	K953168	ULTRACID F DISINFECTING SOLUTION	LBH Cavity Varnish
8 Sep 1995	K953167	ULTRACID DISINFECTING SOLOUTION	LBH Cavity Varnish
5 Sep 1995	K953526	SEEK	LFC Caries Detection Device
29 Aug 1995	K953527	PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS	KLE Resin Tooth Bonding Agent
28 Aug 1995	K953525	ULTRADENT FLOWABLE COMPOSITE	EBF Resin Tooth Shade Material
24 Aug 1995	K953524	ULTRA-BLEND	EJK Calcium Hydroxide Cavity Liner
23 May 1995	K951867	PERMAQUIK BONDING PRIMER	KLE Resin Tooth Bonding Agent
12 May 1995	K951583	PERMAQUIK BONDING PRIMER	KLE Resin Tooth Bonding Agent
10 May 1995	K951582	ULTRADENT PORCELAIN ETCH	EIH Porcelain Powder
23 Mar 1995	K950860	PERMALUTE	KLE Resin Tooth Bonding Agent
23 Mar 1995	K950859	PERMASEAL	EBF Resin Tooth Shade Material
21 Oct 1994	K943370	IMPULSE SEALER PRODUCT LINE	EJI Cartridge Syringe
19 Sep 1994	K943372	CALCIUM HYDROXIDE PASTE	EJK Calcium Hydroxide Cavity Liner
23 Aug 1994	K943373	PERMAGEN F/DC	KLE Resin Tooth Bonding Agent
16 Jun 1994	K941065	DEOX, OXYGEN BARRIER VISCOUS SOLUTION	EMA Dental Cement
27 May 1994	K940860	CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS	ELW Impression Material
13 Sep 1993	K932227	AMELOGEN RESTORATIVE MATERIALS	EBF Resin Tooth Shade Material
9 Sep 1993	K931867	ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE	EBF Resin Tooth Shade Material
22 Jul 1993	K931870	BONDING RESIN PRODUCT LINE	KLE Resin Tooth Bonding Agent
22 Jul 1993	K931869	ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE	EBC Pit and Fissure Sealant and Conditioner
22 Jul 1993	K931868	PRIMADRY PRODUCT LINE	EBC Pit and Fissure Sealant and Conditioner
22 Jul 1993	K925375	CONSEPSIS SCRUB	LBH Cavity Varnish
8 Jul 1993	K924982	CONSEPSIS(TM)	LBH Cavity Varnish
24 Nov 1992	K921408	LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE	EJK Calcium Hydroxide Cavity Liner
28 Sep 1992	K921600	ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE	EBC Pit and Fissure Sealant and Conditioner
28 Sep 1992	K921599	ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN	EBC Pit and Fissure Sealant and Conditioner
9 Sep 1992	K921602	ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT	EBF Resin Tooth Shade Material
9 Sep 1992	K921598	ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE	EBF Resin Tooth Shade Material
9 Sep 1992	K921409	ENAMEL AND PORCELAIN ETCH PRODUCT LINE	EBF Resin Tooth Shade Material
9 Sep 1992	K921407	COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE	EBF Resin Tooth Shade Material
16 Jun 1992	K921601	ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE	JES Dental Floss

Some of these clearances are listed with FDA today by another company: Den-Mat Holdings, LLC (2), NuSmile, Ltd. (1), Dentsply Sirona, Inc. (1).

Also lists devices cleared under other names

Ultradent Products, 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: Kettenbach GmbH & Co. KG (5), Dentsply Sirona, Inc. (4), Ultradent Product, Inc. (2), Avalon Biomed, Inc. (2), Ultradent Products Inc. / Oratech, LLC (2), Guilin Woodpecker Medical Instrument Co., Ltd. (1), NuSmile, Ltd. (1), Cascades Device Consulting Associates (1).

Decided	510(k)	Device	Applicant	Device type
18 Aug 2023	K232498	UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio	Ultradent Product, Inc.	EBC Pit and Fissure Sealant and Conditioner
17 Dec 2021	K211531	Cordless Prophy System, Model: i-Polish	Guilin Woodpecker Medical Instrument Co., Ltd.	EKX Ac-Powered Direct Drive Handpiece
28 Sep 2020	K201795	Transcend	Ultradent Product, Inc.	EBF Resin Tooth Shade Material
11 Jan 2019	K181917	MTA2.3 MATERIALS	NuSmile, Ltd.	KIF Root Canal Filling Resin
1 Sep 2016	K161239	MTA2.2 MATERIAL	Avalon Biomed, Inc.	KIF Root Canal Filling Resin
1 Nov 2013	K132109	ENAMELAST	Ultradent Products Inc. / Oratech, LLC	LBH Cavity Varnish
24 Oct 2013	K132255	ULTRACEM	Ultradent Products Inc. / Oratech, LLC	EMA Dental Cement
27 Dec 2012	K122039	KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B	Kettenbach GmbH & Co. KG	EBG Resin Temporary Crown and Bridge
11 Dec 2012	K122892	MTA2 ROOT AND PULP MATERIALS	Avalon Biomed, Inc.	KIF Root Canal Filling Resin
8 Dec 2010	K102739	HYDROCOLOR 5	Cascades Device Consulting Associates	ELW Impression Material
9 Jan 2009	K083701	PANASIL INITIAL CONTACT AND PANASIL TRAY	Kettenbach GmbH & Co. KG	ELW Impression Material
8 Sep 2008	K082560	PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT	Kettenbach GmbH & Co. KG	ELW Impression Material
6 Aug 2008	K082157	KETTOSIL AND SILGINAT	Kettenbach GmbH & Co. KG	ELW Impression Material
1 May 2008	K081120	FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS	Kettenbach GmbH & Co. KG	ELW Impression Material
25 Jan 2007	K070155	INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC	Osseo Scientific, LLC	EFB Dental Air-Powered Handpiece
20 Apr 2005	K050895	SURPASSON P5 NEWTRON	Satelec	ELC Ultrasonic Scaler
24 Jan 2005	K043118	HYDROGUM SOFT	Dentsply Sirona, Inc.	ELW Impression Material
18 Dec 2002	K024034	OCCLUFAST ROCK	Dentsply Sirona, Inc.	ELW Impression Material
1 Aug 1997	K972239	ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING	Dentsply Sirona, Inc.	ELW Impression Material
16 Jul 1997	K972027	ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)	Dentsply Sirona, Inc.	ELW Impression Material
4 Oct 1991	K913537	MEMOSIL C.D.	Heraeus Kulzer, LLC	ELW Impression Material

Registered establishments

Establishment	Location	What it does
Ultradent Products Inc.FDA reg. 1718912	South Jordan, UT, United States	Contract manufacturer, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1718962). 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.