Registered with FDA

Sanicure BV

SCHIPHOL, Netherlands. Lists 68 dental device types with FDA across 1 registered establishment.

FDA owner/operator10052769Foreign exporter

Device types listed: 68
Brands and models: 13
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1Netherlands

Devices listed with FDA

What Sanicure BV 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	Lister	EBG - CROWN AND BRIDGE, TEMPORARY, RESIN EBF - Material, tooth shade, resinMaterial, tooth shade, resin	2020
Impression MaterialELW · Class 2	Impression materials	Lister	MATERIAL, IMPRESSION	2020
Dental CementEMA · Class 2	Dental cements	Lister	CEMENT, DENTAL	2020
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Lister	AGENT, TOOTH BONDING, RESINMaterial, tooth shade, resin	2022
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Lister	—	2024
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Lister	EBG - CROWN AND BRIDGE, TEMPORARY, RESIN EBF - Material, tooth shade, resin	2025
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Lister	—	2021
Pulp TesterEAT · Class 2	—	Lister	—	2021
Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1	Dental handpieces	Lister	Handpiece, contra- and right-angle attachment, dental	2022
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Lister	—	2024
Amalgam AlloyEJJ · Class 2	—	Lister	—	2020
Root Canal PostELR · Class 1	Root canal filling materials	Lister	—	2020
Cavity VarnishLBH · Class 2	Sealants & varnishes	Lister	—	2025
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Lister	—	2025
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Lister	—	2021
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Lister	—	2022
Dental Diamond InstrumentDZP · Class 1	Dental burs & diamonds	Lister	—	2023
Mouth MirrorEAX · Class 1	Dental hand instruments	Lister	—	2021
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Lister	RESIN, DENTURE, RELINING, REPAIRING, REBASING	2026
Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1	—	Lister	—	2024
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Lister	ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION	2026
Air and/or Water Syringe UnitECB · Class 1	Dental hand instruments	Lister	—	2021
Orthodontic Band PusherECS · Class 1	Dental hand instruments	Lister	—	2025
Dental Belt and/or Gear Driven HandpieceEFA · Class 1	Dental handpieces	Lister	—	2020
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Lister	Handpiece, air-powered, dental	2026
Roll CottonEFN · Class 1	—	Lister	—	2024
Oral Irrigation UnitEFS · Class 1	Oral irrigators	Lister	—	2026
Silicate ProtectorEFX · Class 1	—	Lister	—	2024
Intraoral Dental WaxEGD · Class 1	—	Lister	—	2024
X-Ray Film HolderEGZ · Class 1	—	Lister	—	2021
Prophylaxis CupEHK · Class 1	Polishing & prophylaxis	Lister	—	2022
Abrasive PointEHL · Class 1	Polishing & prophylaxis	Lister	—	2017
Polishing Agent StripEHM · Class 1	Polishing & prophylaxis	Lister	—	2025
Preformed Impression TrayEHY · Class 1	Impression trays	Lister	—	2020
Oral Cavity EvacuatorEHZ · Class 1	Suction & evacuation units	Lister	—	2021
Operative Dental UnitEIA · Class 1	Dental chairs & operative units	Lister	Unit, operative dental	2026
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Lister	—	2020
Rubber DamEIE · Class 1	Rubber dam systems	Lister	—	2024
All Types RetractorEIG · Class 1	Dental hand instruments	Lister	—	2021
Dental Instrument Depth GaugeEIL · Class 1	Dental hand instruments	Lister	—	2024
Rubber Dam Clamp ForcepsEJG · Class 1	Rubber dam systems	Lister	—	2021
Cartridge SyringeEJI · Class 2	Dental needles & syringes	Lister	—	2021
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Lister	—	2025
Dental BurEJL · Class 1	Dental burs & diamonds	Lister	—	2020
Polishing Agent WheelEJQ · Class 1	Polishing & prophylaxis	Lister	—	2024
Operative Cutting InstrumentEKD · Class 1	Dental hand instruments	Lister	—	2025
Endodontic Silver PointEKL · Class 1	—	Lister	—	2024
Gutta-PerchaEKM · Class 1	Root canal filling materials	Lister	—	2021
Endodontic Root Canal PluggerEKR · Class 1	Dental hand instruments	Lister	—	2021
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Lister	—	2021
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Lister	—	2020
Preformed CrownELZ · Class 1	—	Lister	—	2021
Surgical HemostatEMD · Class 1	Dental hand instruments	Lister	—	2021
Surgical Tooth Extractor ForcepsEMG · Class 1	Dental hand instruments	Lister	—	2021
Dental Surgical ElevatorEMJ · Class 1	Dental hand instruments	Lister	—	2023
Periodontic ScalerEMN · Class 1	Dental hand instruments	Lister	—	2021
Periodontic CuretteEMS · Class 1	Dental hand instruments	Lister	—	2021
Matrix RetainerJEP · Class 1	Dental hand instruments	Lister	—	2020
Paper Saliva AbsorberKHR · Class 1	—	Lister	—	2021
Rotary Bone Cutting HandpieceKMW · Class 2	Surgical drills & motors	Lister	HANDPIECE, ROTARY BONE CUTTING	2026
Resin ApplicatorKXR · Class 1	—	Lister	—	2025
Digital Extraoral Source X-Ray SystemMUH · Class 2	Dental X-ray units	Lister	—	2017
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Lister	—	2025
Accessories Operative Dental UnitNRD · Class 1	—	Lister	—	2022
Dental Chair without Operative UnitNRU · Class 1	Dental chairs & operative units	Lister	—	2026
Root Canal Irrigation Air-Powered HandpieceNYL · Class 1	—	Lister	—	2021
Dental Computed Tomography X-RayOAS · Class 2	Dental CBCT	Lister	—	2020
Plaque Disclosing AgentQJC · Class 1	—	Lister	—	2023

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

Sanicure BV 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: Sybron Dental Specialties (15), 3M Company (10), Dentsply Sirona, Inc. (8), 3M Espe Dental Products (7), Jeneric/Pentron, Inc. (5), Heraeus Kulzer, LLC (4), Coltene/Whaledent AG (3), W&H Dentalwerk Buermoos GmbH (3).

Decided	510(k)	Device	Applicant	Device type
11 Mar 2026	K260783	Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One	Kulzer, LLC	EBF Resin Tooth Shade Material
13 Jun 2022	K221695	3M Filtek Supreme Flowable Restorative	3M Company Espe Dental Products	EBF Resin Tooth Shade Material
1 Feb 2022	K220257	Permadyne	3M Deutschland GmbH	ELW Impression Material
5 May 2020	K201184	Lascod Impression Materials	Lascod Spa	ELW Impression Material
2 Jan 2019	K183476	3M Filtek Universal Restorative	3M Espe Dental Products	EBF Resin Tooth Shade Material
28 Nov 2016	K163207	Filtek One Bulk Fill Restorative	3M Company	EBF Resin Tooth Shade Material
15 Nov 2016	K160049	Charisma	Heraeus Kulzer, LLC (Mitsui Chemicals Group)	EBF Resin Tooth Shade Material
27 Jul 2016	K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	Sybron Dental Specialties	KIF Root Canal Filling Resin
27 May 2016	K152826	NoCord	Centrix, Inc.	ELW Impression Material
6 May 2016	K152956	Pulp Canal Sealer, Pulp Canal Sealer EWT	Sybron Dental Specialties	KIF Root Canal Filling Resin
28 Apr 2016	K152927	BRILLIANT EVERGLOW	Coltene/Whaledent AG	EBF Resin Tooth Shade Material
14 Apr 2016	K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	Sybron Dental Specialties	KIF Root Canal Filling Resin
13 Apr 2016	K153174	Ketac Universal Aplicap	3M Deutschland GmbH	EMA Dental Cement
4 Mar 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	Dentply International, Inc.	ELW Impression Material
23 Nov 2015	K143704	Advanced Air System	W&H Dentalwerk Buermoos GmbH	EFB Dental Air-Powered Handpiece
10 Sep 2015	K151526	Zone, ZoneFree, Zone A1	Sybron Dental Specialties	EMA Dental Cement
7 Jul 2015	K150933	iBond Universal & iBond Ceramic Primer	Heraeus Kulzer, LLC (Mitsui Chemicals Group)	KLE Resin Tooth Bonding Agent
8 May 2015	K150217	ORTHOPHOS SL	Dentsply Sirona, Inc.	OAS Dental Computed Tomography X-Ray
5 Feb 2015	K143209	SonicFill 2	Sybron Dental Specialties	EBF Resin Tooth Shade Material
2 Jul 2014	K140685	ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM	Sybron Endo	NYL Root Canal Irrigation Air-Powered Handpiece
8 May 2014	K141081	FILTEK BULK FILL POSTERIOR RESTROATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
11 Mar 2014	K132322	NEWTRON P5 XS B.LED	Satelec - Acteon Group	ELC Ultrasonic Scaler
17 May 2013	K130647	XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML	Heraeus Kulzer, LLC	ELW Impression Material
22 Feb 2013	K123615	IRIS - HIGH STRENGTH GLASS CERAMIC	Dentsply Intl., Inc.	EIH Porcelain Powder
13 Dec 2012	K122269	ENAMIC	Vita Zahnfabrik H. Rauter GmbH & Co. Kg.	EIH Porcelain Powder
6 Nov 2012	K120659	HU-FRIEDY DENTAL CARTRIDGE SYRINGE	Hu-Friedy Mfg Co., LLC	EJI Cartridge Syringe
19 Mar 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
13 Feb 2012	K113406	AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL	Dentsply International, Inc.	ELW Impression Material
14 Dec 2011	K112501	VENUS PEARL PLT REFILL A1	Heraeus Kulzer, LLC	EBF Resin Tooth Shade Material
5 May 2011	K111185	RELYX LUTING PLUS AUTOMIX	3M Espe Dental Products	EMA Dental Cement
5 Apr 2011	K110378	IMPRESSION COMPOUND	Sybron Dental Specialties	ELW Impression Material
21 Jan 2011	K110131	LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
8 Dec 2010	K102984	AURA	Sdi Limited	EBF Resin Tooth Shade Material
12 May 2010	K100235	FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE	3M Company	EBF Resin Tooth Shade Material
29 Aug 2008	K081887	LUTE-IT II VENEER CEMENT, MODEL NO6	Pentron Clinical Technologies	EMA Dental Cement
26 Aug 2008	K081903	XIOS PLUS WALL-MODULE	Dentsply Sirona, Inc.	MUH Digital Extraoral Source X-Ray System
29 Jul 2008	K080939	SURGICAL HANDPIECES, MIKRO SAW HANDPIECES	W&H Dentalwerk Buermoos GmbH	KMW Rotary Bone Cutting Handpiece
14 Mar 2008	K080130	OCCLUFAST CAD	Dentsply Sirona, Inc.	ELW Impression Material
17 Jan 2008	K073395	GILB-2, GLASS IONOMER PROTECTIVE COATING	3M Espe Dental Products	EMA Dental Cement
25 Oct 2006	K062292	UNICEM	3M Espe Dental Products	EMA Dental Cement
19 Oct 2006	K062519	NEXUS 3	Sybron Dental Specialties	EMA Dental Cement
28 Apr 2006	K060472	PREMISE FLOWABLE	Sybron Dental Specialties	EBF Resin Tooth Shade Material
28 Mar 2006	K060469	OPTIBOND ALL-IN-ONE	Sybron Dental Specialties	KLE Resin Tooth Bonding Agent
3 Feb 2006	K053565	TEMPBOND CLEAR WITH TRICLOSAN	Sybron Dental Specialties	EMA Dental Cement
9 Jan 2006	K052820	PARAPOST PARACORE AUTOMIX 5ML	Coltene/Whaledent AG	EBF Resin Tooth Shade Material
23 Jun 2005	K051243	JET BLUE BITE	Coltene/Whaledent AG	ELW Impression Material
15 Dec 2004	K043131	TORPICALGIN	Dentsply Sirona, Inc.	ELW Impression Material
16 Jun 2004	K040906	CALIBRA CEMENT	Dentsply Intl., Inc.	EMA Dental Cement
30 Dec 2003	K033665	VENUS FLOW	Heraeus Kulzer, LLC	EBF Resin Tooth Shade Material
21 Oct 2003	K032465	MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI	Satelec	EBZ Ultraviolet Activator for Polymerization
11 Aug 2003	K032001	POLY Q (GARANT L, PENTA M, PENTA H)	3M Espe AG Dental Products	ELW Impression Material
18 Dec 2002	K024034	OCCLUFAST ROCK	Dentsply Sirona, Inc.	ELW Impression Material
2 Aug 2002	K022476	RELYX RMGIP	3M Company	EMA Dental Cement
22 Apr 2002	K020555	SONATA MICRO HYBRID COMPOSITE	Pentron Laboratory Technologies	EBF Resin Tooth Shade Material
18 Jan 2002	K013510	POINT 4 MODIFIED	Sybron Dental Specialties	EBF Resin Tooth Shade Material
16 Jan 2002	K013647	REVOLUTION FORMULA 2	Sybron Dental Specialties	EBF Resin Tooth Shade Material
5 Oct 2001	K012505	SOPRO595 INTRA ORAL CAMERA	Satelec - Acteon Group	EIA Operative Dental Unit
4 Sep 2001	K012405	EXTRUDE MODIFIED	Sybron Dental Specialties	ELW Impression Material
28 Jun 2001	K011061	SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11	W&H Dentalwerk Buermoos GmbH	EGS Dental Contra- and Right-Angle Attachment Handpiece
7 May 2001	K010475	D/C CORE MATERIAL	Parkell, Inc	EBF Resin Tooth Shade Material
28 Sep 2000	K002452	3M RELY X VENEER CEMENT TRY-IN PASTER	3M Company	EMA Dental Cement
5 Jul 2000	K001218	CORRECT PLUS	Jeneric/Pentron, Inc.	ELW Impression Material
17 Mar 2000	K000211	BUILD-IT FR	Jeneric/Pentron, Inc.	EBF Resin Tooth Shade Material
8 Sep 1999	K992895	IMPREGUM F	Espe Dental AG	ELW Impression Material
8 Sep 1999	K992897	IMPREGUM PENTA	Espe Dental AG	ELW Impression Material
9 Nov 1998	K983266	FIBREKOR POST SYSTEM	Jeneric/Pentron, Inc.	ELR Root Canal Post
24 Aug 1998	K982461	GLASIONOMER CEMENT CX PLUS	Shofu Inc	EMA Dental Cement
21 May 1998	K981091	NEOCOLLOID, ORTHOPRINT	Dentsply Sirona, Inc.	ELW Impression Material
9 Feb 1998	K973221	COMPOSITE 168 RESTORATIVE SYSTEM	Dentsply Intl., Inc.	EBF Resin Tooth Shade Material
29 Jan 1998	K974704	HYDROGUM	Dentsply Sirona, Inc.	ELW Impression Material
17 Dec 1997	K974131	ALERT	Jeneric/Pentron, Inc.	EBF Resin Tooth Shade Material
9 Oct 1997	K973062	TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE	Medidenta Intl., Inc.	EFA Dental Belt and/or Gear Driven Handpiece
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
7 Apr 1997	K970715	SYSTEM B HEAT SOURCE	Sybron Dental Specialties	EAT Pulp Tester
2 Dec 1996	K963862	TOUCH N' HEAT	Sybron Dental Specialties	EAT Pulp Tester
7 Oct 1996	K962812	GLUMA DESENSITIZER/GLUMA 3 PRIMER	Heraeus Kulzer, LLC	KLE Resin Tooth Bonding Agent
18 Jul 1996	K962065	3M VITREBOND LIGHT CURE GLASS IONOMER/BASE	3M Company	EMA Dental Cement
15 Mar 1996	K960547	DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE	Espe GmbH & Co. Kg.	ELW Impression Material
24 Jan 1996	K955285	GALLOY	Southern Dental Industries, Inc.	EJJ Amalgam Alloy
28 Aug 1995	K952662	COMP=FLOW	Jeneric/Pentron, Inc.	EBF Resin Tooth Shade Material
7 Mar 1995	K950514	TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT	3M Unitek Corporation	DYH Resin Bracket and Tooth Conditioner Adhesive
5 Jan 1994	K933139	3M VITREMER LUTING CEMENT	3M Company	EMA Dental Cement
18 Jun 1993	K925027	PHOTAC-FIL APLICAP	Espe GmbH (Us)	EMA Dental Cement
20 Mar 1992	K920424	SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM	3M Company	KLE Resin Tooth Bonding Agent
15 Mar 1991	K905032	MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL	Parkell, Inc	ELW Impression Material
28 Mar 1990	K900436	PROTEMP II	Espe GmbH (Us)	EBG Resin Temporary Crown and Bridge
16 Jun 1989	K892452	PALASEAL(R)	Kulzer, LLC	EBI Rebasing Repairing Relining Denture Resin
11 Aug 1988	K882690	IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL	3M Company	ELW Impression Material
1 Mar 1988	K875133	CAVIT-W	Espe GmbH (Us)	EBG Resin Temporary Crown and Bridge
25 Apr 1986	K861005	GLASIONOMER BASE CEMENT	Shofu Inc	EMA Dental Cement
12 Jan 1982	K813180	SCOTCHBOND DENTAL ADHESIVE	3M Company	KLE Resin Tooth Bonding Agent
15 Jul 1981	K811666	COLTENE COLTEX/COLTOFLAX	Coltene AG	ELW Impression Material
27 Aug 1980	K801639	PERMITE DENTAL AMALGAM ALLOY	Southern Dental Industries, Inc.	EJJ Amalgam Alloy
18 Mar 1980	K800485	VINYL POLYSILOXANE IMPRESSION MATERIAL	3M Company	ELW Impression Material
26 May 1978	K780752	PROPHYLAXIS ANGLE	Young Innovations Inc	EGS Dental Contra- and Right-Angle Attachment Handpiece

Registered establishments

Establishment	Location	What it does
SANICURE BVFDA reg. 3012494290	SCHIPHOL Noord-Holland, Netherlands	Foreign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10052769). 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.