Manufacturer registered with FDA

Coltene/Whaledent AG

Altstaetten, Switzerland. Lists 40 dental device types with FDA across 5 registered establishments, and holds 45 510(k) clearances as applicant.

FDA owner/operator9089944Contract manufacturerManufacturer for exportForeign exporterManufacturer1 clearance in five years

Device types listed: 40
Brands and models: 316
510(k) clearances: 451991–2022
Markets registered in: 172,499 registrations outside the US
Establishments: 5Canada, Switzerland, France +1

510(k) clearances per year, 1990–2026

Registered in 17 markets

Where regulators' registries name Coltene/Whaledent AG as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: SwitzerlandOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Coltene/Whaledent AG	45 clearances	1991–2022	Below
Colombia	INVIMA	Registration holder	COLTENE/WHALEDENT AGCOLTENE / WHALEDENT AG · COLTENE WHALEDENT AG · +2	769	—	Pure Global AI
Canada	Health Canada	Registration holder	COLTENE/WHALEDENT, INC.MICRO-MEGA SA · COLTENE/WHALEDENT AG · +1	647	1999–2026	Pure Global AI
European Union	EUDAMED	Registration holder	Coltene/Whaledent Inc.Coltène/Whaledent GmbH + Co. KG · SciCan Ltd. · +2	352	—	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Coltene Whaledent GmbH + Co. KGColtène/Whaledent AG · COLTENE/WHALEDENT AG · +2	152	—	Pure Global AI
India	CDSCO	Registration holder	Coltene Whaledent Pvt. Ltd.COLTENE WHALEDENT PVT. LTD · COLTENE WHALEDENT PVT. LTD.	120	2023–2026	Pure Global AI
South Korea	MFDS	Manufacturer	Coltene/Whaledent Inc.Coltene/Whaledent AG · COLTENE/WHALEDENT AG · +2	120	1998–2026	Pure Global AI
Taiwan	TFDA	Manufacturer	COLTENE/WHALEDENT AGCOLTENE / WHALEDENT INC. · MICRO MEGA SA · +2	115	2005–2026	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	Coltene/Whaledent AGColtene / Whaledent INC · Coltene/Whaledent GmbH + Co. KG · +1	84	—	Pure Global AI
Australia	TGA	Manufacturer	Coltene Whaledent IncColtene/Whaledent AG · Scican	43	2004–2026	Pure Global AI
Brazil	ANVISA	Manufacturer	MICRO-MEGA SACOLTENE WHALEDENT AG · COLTÈNE\WHALEDENT AG · +2	30	1998–2026	Pure Global AI
China	NMPA	Registration holder	康特威尔登特齿科（瑞士）有限公司Coltène/Whaledent AG康特威尔登特齿科（美国）有限公司Coltène/Whaledent Inc. · 康特威尔登特齿科（德国）有限公司Coltène/Whaledent GmbH + Co. KG · +2	24	—	Pure Global AI
Peru	DIGEMID	Manufacturer	MICRO-MEGA SACOLTENE/WHALEDENT AG · COLTENE / WHALEDENT AG · +2	20	2007–2026	Pure Global AI
Israel	AMAR	Manufacturer	MICRO-MEGA SAColtene Whaledent Inc. · Micro-Mega SA · +2	10	—	Pure Global AI
Japan	PMDA	Registration holder	Ｃｏｌｔｅ（｀）ｎｅ／Ｗｈａｌｅｄｅｎｔ　ＧｍｂＨ＋Ｃｏ．ＫＧＳＣＩＣＡＮ　Ｌｔｄ． · Ｃｏｌｔｅ（‘）ｎｅ／Ｗｈａｌｅｄｅｎｔ　ＧｍｂＨ　＋　Ｃｏ．　ＫＧ · +2	7	2009–2020	Pure Global AI
Egypt	EDA	Manufacturer	Coltene/Whaledent AG,Coltene/Whaledent AG ,	3	2026–2026	Pure Global AI
Serbia	ALIMS	Manufacturer	Coltene/Whaledent GmbH + Co. KG	3	2025–2026	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 Coltene/Whaledent AG 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	BrilliantBRILLIANT Bulk Fill FlowBRILLIANT CriosBRILLIANT EverGlowBRILLIANT EverGlow FlowBrilliant FlowBrilliant New LineBrilliant NGCOMPONEERCOMPONEER Brilliant 10 more COMPONEER Class VFill-Up!MirisParaCoreParaPost ParaCore automixSynergySynergy D6Synergy D6 FlowSynergy FlowSynergy Nano Formula	2007
Impression MaterialELW · Class 2	Impression materials	Maker	AFFINISColtexColtoflaxHydroXtremeJet BiteJet Blue BiteMagic FoamCordPresidentPresident Jet light / regular bodyPresident Plus 4 more President Plus JetPRESIDENT The OriginalRapidSpeedex	2007
Dental CementEMA · Class 2	Dental cements	Maker	Coltosol FDUO TEMPDuoCemParaCem Universal DCSoloCemTempoSIL 2	2007
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	A.R.T. BondNE Self Etch Bond Plus 5mlNE Total Etch Bond 5mlOne Coat 7One Coat 7 UniversalOne Coat 7 Universal, One Coat 7, One Coat 7 ActivatorOne Coat BondOne Coat Bond SLOne Coat Self-Etching BondParaCem Universal DC	2007
Root Canal PostELR · Class 1	Root canal filling materials	Maker	Fiber Lux PlusParaPost Fiber Lux®PARAPOST FIBER WHITEParaPost Fiber White PlusParaPost System®ParaPost Taper Lux®Taper Lux PlusTenax Fiber TransTenax Fiber Trans PlusTENAX WHITE POST	1996
Dental Diamond InstrumentDZP · Class 1	Dental burs & diamonds	Maker	AlpenAlpen Diamond InstrumentsAlpen Speedster Zr PlusAlpen Z-RexDIATECHDiatech Diamond InstrumentsDIATECH Z-Rex	2009
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Maker	Coltolux Comfort LED Curing LightCOLTOLUX LED CURING LIGHT	2008
Rubber DamEIE · Class 1	Rubber dam systems	Maker	Hygenic® Dental Dam KitsHygenic® Elasti-DamHygenic® Fiesta® Dental DamHygenic® Flexi DamROEKO Dental DamWedjets	2003
Ac-Powered Direct Drive HandpieceEKX · Class 1	Dental handpieces	Maker	CanalPro CLCanalPro CL2CanalPro X-Move	2012
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Maker	BioSonic S1 Piezo ScalerBIOSONIC ULTRASONIC SCALER SYSTEMBioSonic US200 UltraSonic Scaler	2008
Dental BurEJL · Class 1	Dental burs & diamonds	Maker	ALPEN SPEEDSTERAlpen® CarbideAlpen® SteriXDiatech CarbideSimplePrep	2007
Polishing Agent WheelEJQ · Class 1	Polishing & prophylaxis	Maker	Alpen Ceramic Plus ShapeGuardAlpen Composite Plus ShapeGuardAlpen PolishersAlpen Zirconia Plus ShapeGuardDisposable KENDA Big JobDisposable KENDA C.G.I.Disposable KENDA Composite MicrofillDisposable KENDA G.P.S.Disposable KENDA HybridDisposable KENDA Nobilis 41 more Disposable KENDA ProphyDisposable KENDA UnicusJiffy CupsJiffy DisksJiffy HiShine CupsJiffy HiShine DisksJiffy HiShine PointsJiffy PointsKENDA Acrylic BlueKENDA All CeramicKENDA AmalgamKENDA BestflexKENDA C.G.I.KENDA CompleteKENDA Composite MicrofillKENDA DeluxeKENDA DiagumKenda ECO Line PolishersKenda ECO Line RemoversKenda ECO Line SmoothersKENDA FG SeriesKENDA High EndKENDA HybridKENDA MaximusKENDA MicrofillKENDA NobilisKENDA Nobilis & UnicusKENDA PlanusKENDA point, abrasiveKENDA POLISHERSKenda PolishetteKENDA Precious MetalsKENDA ProphyKENDA QueenKENDA REDKENDA UnicusKENDA Wheel & KnifeKENDA Yellow LineKENDA Z-SeriesKENDA Zirco1KENDA Zircovis	2010
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Maker	Biosonic Suvi Air Polishing PowderJiffy CupsJiffy DisksJiffy HiShine CupsJiffy HiShine DisksJiffy HiShine PointsJiffy PointsKENDA DENTAL POLISHERSSDI Polishers C.G.I.SDI Polishers Diamond	2014
Root Canal Endodontic PreparerEKQ · Class 1	Endodontic files	Maker	CanalPro EDTAMM-EDTA CREAM	2018
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Maker	H-FilesHEDSTROEM FILESHEDSTROEM FILES Prime LineHERO 642HERO SHAPERHyFlex CMHYFLEX REMOVERK FILESK FILES Prime LineK-Files 22 more MicroMega One Curve MiniMicroMega One Curve Mini Procedure PackMicroMega One GliderMicroMega One ReciMicroMega One Reci Procedure PackMicroMega Reci GliderMicroMega REMOVERMM K-Files, MM H-Files, MM K-ReamersMM TAPERMMC FILESMME FilesOne curveONE CURVE PROCEDURE PACKONE CURVE STARTER PACKONE FLAREONE-GR-ENDOREMOVER2 Shape Mini2 Shape Mini Procedure Pack2Shape2Shape Procedure Pack	2010
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	Dental Endodontic Cement Mod.MM-SEAL	2008
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Maker	Bondent® DrillsKodex® DrillsMax® DrillsParaPost® DrillsParaPost® Fiber Lux DrillsParaPost® Taper Lux DrillsParaPost® X DrillsParaPost® XH DrillsParaPost® XP DrillsParaPost® XT Drills 2 more Starter DrillUnity® Drills	2002
Dental NeedleDZM · Class 1	Dental needles & syringes	Maker	CanalPro Irrigating Tips	2012
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	Bending ToolsMetal Wrench AMetal Wrench BParapost Paraform including: Coreformer Refills, Sets & Kits	2011
Pulp TesterEAT · Class 2	—	Maker	Endo X-Move BundleENDO-ICEENDO-ICE GREEN	2024
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	Cool Temp Natural	2007
Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1	—	Maker	Bondent® Dentin Bonding PinsMax® Restorative PinsTMS Link Plus®TMS Link Plus® MinimTMS Link Plus® RegularTMS Link® MinikinTMS Link® MinimTMS Link® MinutaTMS Link® RegularTMS® Minikin 4 more TMS® MinimTMS® MinutaTMS® RegularUnity® Restorative Pins	1996
Rubber Dam ClampEEF · Class 1	Rubber dam systems	Maker	Hygenic® Brinker ClampsHygenic® Dental Dam Clamp-SetsHygenic® Dental Dam ClampsHygenic® Fiesta® Color Coded Matte Finish ClampsHygenic® Fiesta® Color Coded Matte Finish Winged ClampsHygenic® Fiesta® Color Coded Matte Finish Wingless ClampsHygenic® Gloss Finish Winged ClampsHygenic® Gloss Finish Wingless Clamps	2003
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Lister	K-Spray Handpiece SpraySTATCARE Handpiece SpraySTATMATIC Spray	2018
Intraoral Dental WaxEGD · Class 1	—	Maker	Boxing WaxExtra Tough WaxHygenic® Bite WafersHygenic® Bite Wafers, Extra, Hard, GreenHygenic® Bite Wafers, Laminated, BlueHygenic® Bite Wafers, Soft, YellowHygenic® Medium-Soft No. 3 Pink WaxHygenic® Occlusal Rim WaxHygenic® Orthodontic Tray WaxHygenic® Orthodontic Tray Wax Sticks 5 more Hygenic® Red WaxHygenic® Round Wax StripsHygenic® Square Wax RopesPlastic Wax SticksYellow Bite Wax	1996
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Maker	Diatech, SwissTEC DisksDisposable KENDA Big JobDisposable KENDA C.G.I.Disposable KENDA Composite MicrofillDisposable KENDA G.P.S.Disposable KENDA HybridDisposable KENDA NobilisDisposable KENDA ProphyDisposable KENDA UnicusKENDA All Ceramic 16 more KENDA AmalgamKENDA C.G.I.KENDA CompleteKENDA Composite MicrofillKENDA DeluxeKENDA Dental PolishersKENDA DiagumKENDA FG SeriesKENDA HybridKENDA MaximusKENDA NobilisKENDA PlanusKENDA Precious MetalsKENDA ProphyKENDA UnicusKENDA Zircovis	2013
Abrasive PointEHL · Class 1	Polishing & prophylaxis	Maker	Diatech, SwissTEC, SwissBursDisposable KENDA Big JobDisposable KENDA C.G.I.Disposable KENDA Composite MicrofillDisposable KENDA G.P.S.Disposable KENDA HybridDisposable KENDA NobilisDisposable KENDA ProphyDisposable KENDA UnicusKENDA All Ceramic 16 more KENDA AmalgamKENDA C.G.I.KENDA CompleteKENDA Composite MicrofillKENDA DeluxeKENDA Dental PolishersKENDA DiagumKENDA FG SeriesKENDA HybridKENDA MaximusKENDA NobilisKENDA PlanusKENDA Precious MetalsKENDA ProphyKENDA UnicusKENDA Zircovis	2013
Polishing Agent StripEHM · Class 1	Polishing & prophylaxis	Lister	Alpen Polishers	2010
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	PRESIDENT TRAY	1996
Irrigating Endodontic Periodontic SyringeEIC · Class 1	Dental hand instruments	Maker	CanalPro Color Syringes	2012
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	Tip Dispenser	2018
Dental Retractor AccessoriesEIF · Class 1	Dental hand instruments	Maker	AUTOCLAVABLEKENDA PracticusPolisher & bur caddyPOLISHER+BURR CADDY	2021
Dental Instrument HandleEJB · Class 1	Dental hand instruments	Maker	DENTAL DAM PUNCH	2003
Rubber Dam FrameEJE · Class 1	Rubber dam systems	Maker	Dental Dam Frame	2003
Rubber Dam Clamp ForcepsEJG · Class 1	Rubber dam systems	Maker	Dental Dam Forceps	2003
Endodontic Pulp Canal ReamerEKP · Class 1	Endodontic files	Maker	K REAMERSK REAMERS Prime LineK-Reamers	2019
Endodontic BroachEKW · Class 1	Endodontic files	Maker	NERVE BROACHES	2019
Dental Electrosurgical Unit and AccessoriesEKZ · Class 2	—	Maker	PerFect TCS II	2008
Paper Saliva AbsorberKHR · Class 1	—	Maker	ORA SHIELD	2003
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	Accutrac Die System Including: Accessories, Kits,Pindex System & AccessoriesProxima (Procma) Saw Blades	2011

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 Coltene/Whaledent AG as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
13 Jan 2022	K220097	PRESIDENT The Original	ELW Impression Material
29 Oct 2019	K191385	BRILLIANT COMPONEER	EBF Resin Tooth Shade Material
21 Jun 2019	K190597	BRILLIANT EverGlow Flow	EBF Resin Tooth Shade Material
15 Aug 2018	K181500	BRILLIANT Crios	EBF Resin Tooth Shade Material
16 Nov 2016	K160800	DuoCem	EMA Dental Cement
28 Apr 2016	K152927	BRILLIANT EVERGLOW	EBF Resin Tooth Shade Material
9 Dec 2015	K152243	One Coat 7 Universal	KLE Resin Tooth Bonding Agent
23 Jun 2015	K150218	Fill-Up!	EBF Resin Tooth Shade Material
31 Jan 2014	K132356	SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST	EGS Dental Contra- and Right-Angle Attachment Handpiece
23 Aug 2013	K130137	BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER	ELC Ultrasonic Scaler
8 Jan 2013	K121621	SOLOCEM	EMA Dental Cement
21 Nov 2011	K112168	COMPONEER	EBF Resin Tooth Shade Material
24 Jul 2009	K090937	E-STATIS 40 SYSTEM	EBW Handpiece and Cord Foot Controller
6 Feb 2009	K083304	TEMPOSIL 2	EMA Dental Cement
4 Feb 2008	K073319	STATMATIC 31 HANDPIECE MAINTENANCE UNIT	EFB Dental Air-Powered Handpiece
16 Nov 2007	K072604	DUO TEMP	EMA Dental Cement
18 Oct 2007	K071632	PERFECT TISSUE CONTOURING SYSTEM II	EKZ Dental Electrosurgical Unit and Accessories
13 Sep 2007	K071891	STATIS DENTAL HANDPIECES	EFB Dental Air-Powered Handpiece
19 Oct 2006	K062418	K-SPRAY, MODEL 085-2715	EFB Dental Air-Powered Handpiece
9 Jan 2006	K052820	PARAPOST PARACORE AUTOMIX 5ML	EBF Resin Tooth Shade Material
9 Nov 2005	K053040	PARACEM UNIVERSAL DC	EMA Dental Cement
23 Jun 2005	K051243	JET BLUE BITE	ELW Impression Material
18 Mar 2005	K050426	TEMPOSIL, MODEL 6720	EMA Dental Cement
9 Feb 2005	K050013	RETRACTOFOAM	ELW Impression Material
15 Mar 2004	K040551	COLTOLUX LED CURING LIGHT	EBZ Ultraviolet Activator for Polymerization
23 Jan 2004	K033760	ONE COAT SE BOND	KLE Resin Tooth Bonding Agent
5 Aug 2003	K031752	COLTOSOL F	EMA Dental Cement
10 Dec 2001	K013400	SYNERGY FLOW	EBF Resin Tooth Shade Material
30 Nov 2000	K003034	COLTENE AURA COMPOMER RESTORATIVE SYSTEM	EBF Resin Tooth Shade Material
14 Apr 2000	K993545	TENAX WHITE POST	ELR Root Canal Post
14 Mar 2000	K000311	PARAPOST FIBER WHITE	ELR Root Canal Post
21 Dec 1999	K993710	MODIFICATION OF PARAPOST CEMENT	EMA Dental Cement
20 Jan 1999	K983727	BIOSONIC ULTRASONIC SCALER SYSTEM	ELC Ultrasonic Scaler
24 Mar 1998	K974906	ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM	KLE Resin Tooth Bonding Agent
9 Mar 1998	K974465	SYNERGY	EBF Resin Tooth Shade Material
16 May 1997	K970649	HERO 642	EKS Endodontic Pulp Canal File
4 Feb 1997	K964691	TCB TEMPORARY CROWN AND BRIDGE MATERIAL	EBG Resin Temporary Crown and Bridge
24 May 1995	K950106	COLTOLUX LIGHT METER	EBZ Ultraviolet Activator for Polymerization
24 May 1995	K945698	COLTOLUX 3, COLTOLUX 4	EBZ Ultraviolet Activator for Polymerization
2 Feb 1995	K945366	PARAPOST CEMENT	EMA Dental Cement
11 Jan 1995	K945142	POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)	ELW Impression Material
21 Sep 1994	K933639	IMKB CONTRA-ANGLES	EGS Dental Contra- and Right-Angle Attachment Handpiece
6 Jun 1994	K934192	PARAPOST XT SYSTEM	ELR Root Canal Post
3 Aug 1992	K922615	COLTENE A.R.T. BOND	KLE Resin Tooth Bonding Agent
25 Jul 1991	K912485	COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC	ELW Impression Material

Some of these clearances are listed with FDA today by another company: Dent4You AG (7), SycoTec GmbH & Co KG (3), Dentsply Sirona, Inc. (3), Dentalez, Inc. (2), A-dec, Inc. (1), TUNAP GmbH & Co. KG (1).

Also lists devices cleared under other names

Coltene/Whaledent AG 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: Coltene AG (4), Guilin Woodpecker Medical Instrument Co., Ltd. (2), The Hygenic Company, LLC (2), Saeyang Microtech Co., Ltd. (1), Dxm Co., Ltd. (1), Meta Biomed Co, Ltd (1), Nsk Nakanishi, Inc. (1), Bauer, Cheng & Associates, Inc. (1).

Decided	510(k)	Device	Applicant	Device type
10 May 2021	K203320	Endo Motor	Guilin Woodpecker Medical Instrument Co., Ltd.	EKX Ac-Powered Direct Drive Handpiece
16 Aug 2013	K123582	ENDO A CLASS	Saeyang Microtech Co., Ltd.	EKX Ac-Powered Direct Drive Handpiece
27 Nov 2012	K121093	D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000	Dxm Co., Ltd.	EBZ Ultraviolet Activator for Polymerization
21 Aug 2006	K053555	ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L	Guilin Woodpecker Medical Instrument Co., Ltd.	ELC Ultrasonic Scaler
24 Nov 2004	K042769	ADSEAL ROOT CANAL SEALER	Meta Biomed Co, Ltd	KIF Root Canal Filling Resin
13 May 2004	K041098	COOL TEMP NATURAL	Coltene AG	EBG Resin Temporary Crown and Bridge
24 Mar 1999	K990682	PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)	Nsk Nakanishi, Inc.	EKX Ac-Powered Direct Drive Handpiece
16 Apr 1990	K900844	WEDJETS	The Hygenic Company, LLC	EIE Rubber Dam
10 Jan 1990	K894092	DENTAL ENDODONTIC CEMENT (MODIFICATION)	The Hygenic Company, LLC	KIF Root Canal Filling Resin
29 Jan 1987	K870047	COLTENE RAPID	Coltene AG	ELW Impression Material
16 Mar 1984	K840085	COLTENE BRILLIANT	Bauer, Cheng & Associates, Inc.	EBF Resin Tooth Shade Material
15 Jul 1981	K811666	COLTENE COLTEX/COLTOFLAX	Coltene AG	ELW Impression Material
15 Jul 1981	K811767	COLTENE PRESIDENT IMPRESSION MATERIALS	Coltene AG	ELW Impression Material

Registered establishments

Establishment	Location	What it does
COLTENE/WHALEDENT AGFDA reg. 9613375	ALTSTAETTEN Sankt Gallen, Switzerland	Contract manufacturer, Manufacturer
COLTENE/WHALEDENT INC.FDA reg. 2416455	CUYAHOGA FALLS, OH, United States	Contract manufacturer, Manufacturer for export, Manufacturer, Repacker / relabeler, Specification developer
DIATECH DENTAL INCFDA reg. 3012832388	Cuyahoga Falls, OH, United States	Manufacturer
Micro-Mega SAFDA reg. 8030962	BESANCON Doubs, France	Contract manufacturer, Foreign exporter, Manufacturer
SCICAN LTD.FDA reg. 8043629	TORONTO Ontario, Canada	Foreign exporter, Private-label distributor

Other names on FDA records

Micro-Mega · Scican, Ltd. · DIA TECH Dental AG

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9089944). 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.