Data / Medical devices / Netherlands / Dentsply Ih BV

Dentsply Ih BV: FDA-registered device maker in Sevenum Limburg, Netherlands, 93 510(k) clearances

Name: Dentsply Ih BV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dentsply Ih BV is registered with the FDA (registration 3011824442) in Sevenum Limburg, Netherlands. It lists 41 device types. The FDA files 93 510(k) clearances under its listings, the newest dated September 4, 2026. Registered through 2027. FDA data exported November 3, 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.

Get makers like this one Watch Dentsply Ih BV

FDA registration number: 3011824442
Address: Piri Reisweg 23, Sevenum Limburg, Netherlands, 5975 RZ
Owner or operator: DENTSPLY SIRONA INC (2511302)
Roles: Exporter to the US
First device listed: December 28, 1977
Registered through: 2027
Brand names listed: Adaptable Composite Resin, Ankylos Cercon Balance, Ankylos Temporary Abutment Balance, CELTRA Duo, Caulk Post & Core Kit, Celtra Ceram, Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit, Cercon Abutments and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Exporter to the US	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Exporter to the US	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Exporter to the US	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Exporter to the US	accessdata.fda.gov
Alloy, Gold-Based Noble Metal	EJT	2	Exporter to the US	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Exporter to the US	accessdata.fda.gov
Anchor, Preformed	EJX	1	Exporter to the US	accessdata.fda.gov
Applicator, Resin	KXR	1	Exporter to the US	accessdata.fda.gov
Barrier, Animal Source, Intraoral	NPL	2	Exporter to the US	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Bone Grafting Material, Animal Source	NPM	2	Exporter to the US	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Exporter to the US	accessdata.fda.gov
Broach, Endodontic	EKW	1	Exporter to the US	accessdata.fda.gov
Cement, Dental	EMA	2	Exporter to the US	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Exporter to the US	accessdata.fda.gov
Chisel, Osteotome, Surgical	EMM	1	Exporter to the US	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Exporter to the US	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Exporter to the US	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Exporter to the US	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Exporter to the US	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Exporter to the US	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Exporter to the US	accessdata.fda.gov
Handpiece, Rotary Bone Cutting	KMW	2	Exporter to the US	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Exporter to the US	accessdata.fda.gov
Instrument, Cutting, Operative	EKD	1	Exporter to the US	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Exporter to the US	accessdata.fda.gov
Locator, Root Apex	LQY	U	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Exporter to the US	accessdata.fda.gov
Plate, Bone	JEY	2	Exporter to the US	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Exporter to the US	accessdata.fda.gov
Powder, Porcelain	EIH	2	Exporter to the US	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Exporter to the US	accessdata.fda.gov
Punch, Biopsy, Surgical	EME	1	Exporter to the US	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Exporter to the US	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Exporter to the US	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Exporter to the US	accessdata.fda.gov

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
September 4, 2026	K261935	Surgical and Prosthetic Trays	KCT	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
February 13, 2025	K243546	AH Plus Endodontic Sealer	KIF	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
December 10, 2024	K242025	Elos Accurate® Hybrid Base	NHA	Substantially Equivalent	Elos Medtech Pinol A/S	accessdata.fda.gov
October 24, 2024	K242462	CEREC Cercon 4D CAD/CAM Blocks	EIH	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
August 28, 2024	K241557	Cercon® yo ML	EIH	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
July 24, 2024	K233865	X-Smart Pro; X-Smart Pro+	EKX	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
May 7, 2024	K234018	CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
January 16, 2024	K231144	Washtrays	KCT	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
March 22, 2023	K221402	CEREC Tessera Abutment Block, CEREC Tessera Abutment System	NHA	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
November 16, 2022	K221094	OmniTaper EV Dental Implants, DS Implants abutments with EV connection	DZE	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
November 16, 2022	K220841	PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)	DZE	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
May 3, 2022	K220791	Surgical and Prosthetic Trays	KCT	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
March 4, 2022	K212281	Surgical Trays	KCT	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
November 15, 2021	K213449	DS Implants abutments provided with the EV connection	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
August 27, 2021	K210610	PrimeTaper EV Dental Implant	DZE	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
February 24, 2021	K201703	PROXEO Twist Cordless Polishing System PL-40 H	EKX	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
January 20, 2021	K202629	Dentsply Sirona Universal Spray Glazes	EIH	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
March 3, 2020	K193064	Atlantis suprastructures	NHA	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
July 10, 2019	K183079	Conometric Abutments	NHA	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
December 18, 2018	K182422	Lucitone Denture Base Materials	EBI	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
November 20, 2018	K182288	TPH Spectra ST Flowable Composite Restorative	EBF	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
September 28, 2018	K181476	Prime&Bond active Universal Adhesive	KLE	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
April 4, 2018	K172239	SIMPLANT 18	LLZ	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
March 31, 2017	K163350	Multibase Abutments EV and ATLANTIS Suprastructures	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
February 24, 2017	K162888	Cercon	EIH	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
February 9, 2017	K162158	Porcine Anorganic Bone Mineral in Delivery Applicator	NPM	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
November 23, 2016	K161957	W&H Implantmed SI-1015 incl. Accessories	EBW	Substantially Equivalent	W&H Dentalwerk Burmoos GmbH	accessdata.fda.gov
September 27, 2016	K162107	TPH Spectra+ Universal Composite Restorative	EBF	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
August 12, 2016	K161269	CELTRA Press	EIH	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
July 28, 2016	K161118	SIMPLANT Online Case Review and SIMPLANT Editor	LLZ	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
June 7, 2016	K160232	Disposable Barrier Sleeves and Covers	PEM	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
November 24, 2014	K142496	Collagen Dental Membrane - Conformable IIBP	NPL	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
August 20, 2014	K140347	ANKYLOS C/X IMPLANT SYSTEM	DZE	Substantially Equivalent	Dentsply Intl., Inc.	accessdata.fda.gov
July 16, 2014	K140714	PORCINE ANORGANIC BONE MINERAL	NPM	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
January 22, 2014	K131644	ANKYLOS SYNCONE ABUTMENT 5(DEGREE)	NHA	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
October 25, 2013	K130999	OSSEOSPEED PROFILE EV	DZE	Substantially Equivalent	Dentsply Implants Manufacturing GmbH	accessdata.fda.gov
February 22, 2013	K123615	IRIS - HIGH STRENGTH GLASS CERAMIC	EIH	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
February 1, 2013	K123545	INCORIS TZI	EIH	Substantially Equivalent	Sirona Dental Systems GmbH	accessdata.fda.gov
January 23, 2013	K121810	OSSEOSPEED ANGLED ABUTMENT EV	NHA	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
December 11, 2012	K122268	ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS	NHA	Substantially Equivalent	Dentsply International	accessdata.fda.gov
July 31, 2012	K120414	OSSEOSPEED PLUS	DZE	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
May 4, 2012	K112671	STERILCONTAINER SYSTEM	KCT	Substantially Equivalent	Aesculap, Ltd.	accessdata.fda.gov
November 9, 2011	K112152	CERCON HT	EIH	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
June 21, 2011	K101005	ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT	NHA	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
February 23, 2011	K101732	ASTRA TECH IMPLANT SYSTEM	DZE	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
December 16, 2010	K102341	VIPI BLOCK	EBG	Substantially Equivalent	Vipi Industria,Comercio,Exportacao E Importacao DE	accessdata.fda.gov
May 22, 2009	K083805	ANKYLOS C/X DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Dentsply Intl., Inc.	accessdata.fda.gov
April 14, 2009	K083841	ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL	EBF	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
September 17, 2008	K080156	OSSEOSPEED TM PROFILE SYSTEM	DZE	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
July 29, 2008	K080939	SURGICAL HANDPIECES, MIKRO SAW HANDPIECES	KMW	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
April 30, 2008	K080396	OSSEOSPEED NARROW	DZE	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
March 27, 2008	K072730	FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS	NHA	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
February 15, 2008	K073067	ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS	DZE	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
February 12, 2008	K073073	ANKYLOS TEMPORARY ABUTMENT BALANCE	NHA	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
October 1, 2007	K072624	ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT	NHA	Substantially Equivalent	Astra Tech AB	accessdata.fda.gov
April 27, 2007	K063779	OSSEOSPEED 4.0S-6MM, MODEL 24619	DZE	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
March 14, 2007	K070538	XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE	KLE	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
May 3, 2006	K060287	DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM	EBW	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
March 24, 2006	K053384	FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM	DZE	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
June 24, 2005	K051462	MODIFICATION TO: CERCON BASE	EIH	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
June 14, 2005	K050208	FRIADENT ESTHETICAP	NHA	Substantially Equivalent	Dentsply International	accessdata.fda.gov
April 22, 2005	K050880	DYRACT EXTRA RESTORATIVE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
August 26, 2004	K041509	ANKYLOS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
June 24, 2004	K041372	SMARTLITE PS PEN-STYLE LED CURING LIGHT	EBZ	Substantially Equivalent	Dentsply International	accessdata.fda.gov
April 1, 2004	K040144	QUIXX POSTERIOR RESTORATIVE	EBF	Substantially Equivalent	Dentsply International	accessdata.fda.gov
March 18, 2004	K040421	DUCERAGOLD PORCELAINS	EIH	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
March 18, 2004	K040420	DUCERAM PLUS CERAMIC SYSTEM	EIH	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
October 2, 2003	K032302	XIVE TG ABUTMENTS	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
August 12, 2003	K030639	XIVE 3.0 DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Friandent GmbH	accessdata.fda.gov
March 3, 2003	K024004	XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
November 7, 2002	K023631	ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS	NHA	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
September 6, 2002	K022796	CERCON CERAM S PORCELAIN	EIH	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
July 2, 2002	K021318	XIVE DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
April 9, 2002	K013067	FRIALOC DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
March 15, 2002	K013867	XIVE DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
December 20, 2001	K013438	FRIALIT-2 ESTHETICBASE ABUTMENT	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
June 28, 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	EGS	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
April 20, 2000	K994174	FRIALIT-2 MH-2 ABUTMENT	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
March 24, 2000	K994376	FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA	DZE	Substantially Equivalent	Friadent GmbH	accessdata.fda.gov
July 15, 1999	K990304	MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM	DZE	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
November 19, 1998	K974738	ASTRA TECH IMPLANT DENTAL SYSTEM	DZE	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
October 22, 1998	K982576	FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476	DZE	Substantially Equivalent	Friatec AG	accessdata.fda.gov
September 4, 1998	K980630	FRIALIT-2 CORABASE	DZE	Substantially Equivalent	Friatec AG	accessdata.fda.gov
May 7, 1998	K973924	FRIOS BONESHIELD	JEY	Substantially Equivalent	Friatec AG	accessdata.fda.gov
March 19, 1998	K980698	ASTRA TECH IMPLANTS - DENTAL SYSTEM	DZE	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
August 6, 1997	K972278	CYTOPLAST REGENTEX TITANIUM 250	LYC	Substantially Equivalent	Osteogenics Co.	accessdata.fda.gov
March 11, 1997	K964342	CYTOPLAST GBR	LYC	Substantially Equivalent	Osteogenics Co.	accessdata.fda.gov
April 26, 1996	K960548	AH PLUS ROOT CANAL SEALER	KIF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
March 15, 1996	K945847	FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE	DZE	Substantially Equivalent	Friatec Medical Inc., USA	accessdata.fda.gov
February 8, 1994	K931767	ASTRA TECH IMPLANTS-DENTAL SYSTEM	DZE	Substantially Equivalent	Astra Tech, Inc.	accessdata.fda.gov
June 22, 1992	K921479	DUCERATIN/DUCERAM LFC DENTAL PORCELAIN	EIH	Substantially Equivalent	Degussa AG	accessdata.fda.gov
December 27, 1979	K792558	CONTAINER SYSTEM	FLE	Substantially Equivalent	Aesculap Instruments Corp.	accessdata.fda.gov
February 28, 1978	K780301	CAULK TYLOK	EMA	Substantially Equivalent	L.D. Caulk Co.	accessdata.fda.gov

Compare with other makers

Updated September 4, 2026. 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.