Not currently registered with FDA under this name

Dentsply International, Inc.

York, PA, United States. Named as applicant on 56 dental 510(k) clearances between 2001 and 2016. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 562001–2016
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Dentsply International, 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	Applicant	Dentsply International, Inc.	56 clearances	2001–2016	Below
Brazil	ANVISA	Manufacturer	DENTSPLY INTERNATIONAL INC	1	2018–2018	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

510(k) clearances

Clearances on which FDA names Dentsply International, Inc. as the applicant.

Decided	510(k)	Device	Device type
21 Sep 2016	K160207	ATLANTIS ISUS Implant Suprastructures	NHA Endosseous Dental Implant Abutment
19 Feb 2016	K151439	ATLANTIS ISUS	NHA Endosseous Dental Implant Abutment
29 Jan 2016	K152247	ATLANTIS Crown	EIH Porcelain Powder
14 Jan 2016	K151039	ATLANTIS Abutment for NobelActive 3.0	NHA Endosseous Dental Implant Abutment
30 Oct 2015	K151619	Prime&Bond Elect Universal Dental Adhesive	KLE Resin Tooth Bonding Agent
16 Jun 2015	K150535	Cavitron Touch Ultrasonic Scaling System	ELC Ultrasonic Scaler
26 Feb 2015	K142178	PROROOT MTA WHITE, PROROOT MTA GRAY	KIF Root Canal Filling Resin
22 Jan 2014	K131644	ANKYLOS SYNCONE ABUTMENT 5(DEGREE)	NHA Endosseous Dental Implant Abutment
11 Oct 2013	K132145	MTM(R) CLEAR ALIGNER	NXC Sequential Aligner
5 Jul 2013	K122424	ISUS IMPLANT SUPRASTRUCTURES	NHA Endosseous Dental Implant Abutment
24 May 2013	K123925	MTM CLEAR ALIGNER IN-OFFICE	NXC Sequential Aligner
11 Dec 2012	K122268	ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS	NHA Endosseous Dental Implant Abutment
15 Oct 2012	K122331	CAVITY VARNISH	LBH Cavity Varnish
6 Aug 2012	K121698	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	EJR Oral Cavity Abrasive Polishing Agent
13 Feb 2012	K113406	AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL	ELW Impression Material
9 Nov 2011	K112152	CERCON HT	EIH Porcelain Powder
6 Jun 2011	K110753	MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM	EKX Ac-Powered Direct Drive Handpiece
26 May 2011	K103653	E3 TORQUE CONTROL MOTOR	EBW Handpiece and Cord Foot Controller
19 Aug 2010	K101493	ADVANCED GLASS IONOMER (K-130) RESTORATIVE	EMA Dental Cement
28 Aug 2009	K091706	QUATTRO PORCELAIN SYSTEM	EIH Porcelain Powder
14 Apr 2009	K083841	ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL	EBF Resin Tooth Shade Material
10 Feb 2009	K083326	FLUOROCORE 2	EBF Resin Tooth Shade Material
31 Mar 2008	K073075	FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS	DZE Root-Form Endosseous Implant
15 Feb 2008	K073067	ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS	DZE Root-Form Endosseous Implant
12 Feb 2008	K073073	ANKYLOS TEMPORARY ABUTMENT BALANCE	NHA Endosseous Dental Implant Abutment
12 Oct 2007	K072713	ION DENTAL RESIN SYSTEM	EBI Rebasing Repairing Relining Denture Resin
3 Oct 2007	K072342	SULTAN TOOTH ROOT DESENSITIZER	LBH Cavity Varnish
8 Aug 2007	K072052	OSTEOGRAF/D-300	LYC Synthetic Bone Grafting Material
6 Aug 2007	K072057	OSTEOGRAF/LD-300	LYC Synthetic Bone Grafting Material
6 Aug 2007	K072056	OSTEOGRAF/D-700	LYC Synthetic Bone Grafting Material
2 May 2007	K070307	STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT	ELC Ultrasonic Scaler
22 Mar 2007	K070306	PAINT- ON POLISH AGENT	EBD Resin Filling Material Coating
28 Jul 2006	K061580	ECLIPSE WAX REMOVER	EBI Rebasing Repairing Relining Denture Resin
23 May 2006	K061264	TEMPFX ESTHETIC PROVISIONAL SYSTEM	EBG Resin Temporary Crown and Bridge
10 Apr 2006	K060837	IN-OVATION C	NJM Orthodontic Ceramic Bracket
29 Mar 2006	K053368	INTERPROXIMAL REDUCTION SYSTEM	EFB Dental Air-Powered Handpiece
17 Feb 2006	K060293	TEMPORARY CROWN AND BRIDGE MATERIAL	EBG Resin Temporary Crown and Bridge
1 Nov 2005	K052370	CP BRACKET SYSTEM	DYW Orthodontic Plastic Bracket
12 Aug 2005	K052097	CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE	EBF Resin Tooth Shade Material
14 Jun 2005	K050208	FRIADENT ESTHETICAP	NHA Endosseous Dental Implant Abutment
11 May 2005	K050959	DELTON ILLUMINATING PIT AND FISSURE SEALING	EBC Pit and Fissure Sealant and Conditioner
23 Feb 2005	K050386	PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM	KLE Resin Tooth Bonding Agent
24 Jun 2004	K041372	SMARTLITE PS PEN-STYLE LED CURING LIGHT	EBZ Ultraviolet Activator for Polymerization
16 Jun 2004	K041343	XENO NM LIGHT CURED DENTAL ADHESIVE	KLE Resin Tooth Bonding Agent
16 Jun 2004	K041335	PTM SYSTEM	EIH Porcelain Powder
1 Apr 2004	K040144	QUIXX POSTERIOR RESTORATIVE	EBF Resin Tooth Shade Material
4 Dec 2003	K033705	BOBCAT PRO SCALER SYSTEM, MODEL G-130	ELC Ultrasonic Scaler
1 Oct 2003	K032320	APPOLLO 3 ALLOY	EJT Gold-Based Noble Metal Alloy
30 Sep 2003	K032321	CERA F ALLOY	EJT Gold-Based Noble Metal Alloy
30 Sep 2003	K032319	CERA R PLUS ALLOY	EJT Gold-Based Noble Metal Alloy
30 Sep 2003	K032318	MINERVA 58 ALLOY	EJT Gold-Based Noble Metal Alloy
26 Sep 2003	K032851	ULTRACROWN 75 ALLOY	EJT Gold-Based Noble Metal Alloy
21 Jul 2003	K031615	SLED CURING LIGHT SYSTEM	EBZ Ultraviolet Activator for Polymerization
7 Feb 2003	K030111	DIAMONDCOAT ULTRASONIC INSERTS	ELC Ultrasonic Scaler
6 Nov 2002	K023697	STERI-MATE STERILIZABLE HANDPIECE	ELC Ultrasonic Scaler
2 May 2001	K011009	WHITE MTA MATERIAL	KIF Root Canal Filling Resin

Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (25), Rmo, Inc. (1).

Sources

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 of the most recent filing, which can be a US agent.