Manufacturer registered with FDA
Dentaurum GmbH & Co. KG
Ispringen, Germany. Lists 48 dental device types with FDA across 1 registered establishment.
- Device types listed
- 48
- Brands and models
- 265
- 510(k) clearances
- 0as applicant
- Markets registered in
- 151,138 registrations outside the US
- Establishments
- 1Germany
Registered in 15 markets
Where regulators' registries name Dentaurum GmbH & Co. KG as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dentaurum GmbH & Co. KG | 48 device types | — | Below |
| Canada | Health Canada | Registration holder | DENTAURUM GMBH & CO. KG | 597 | 1999–2021 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Dentaurum GmbH & Co. KG | 242 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | DENTAURUM GMBH & CO. KG | 58 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Dentaurum GmbH & Co. KG | 56 | 2023–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dentaurum GmbH & Co.KGDENTAURUM GmbH & Co. KG | 52 | 1998–2016 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dentaurum GmbH & Co. KG | 47 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTAURUM GMBH&CO.KGDENTAURUM GMBH & CO KG. | 33 | 2009–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTAURUM GMBH & CO. KGDentaurum GmbH & Co. KG | 15 | 2013–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Dentaurum GmbH & Co KG | 14 | 2004–2018 | Pure Global AI |
| China | NMPA | Registration holder | 德国登特仑有限公司Dentaurum GmbH & Co.KG德国登特仑有限公司Dentaurum GmbH & Co. KG | 11 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | DENTAURUM GmbH & Co. KG,Dentaurum GmbH & Co. KG, | 5 | 2025–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Dentaurum GmbH & Co. KG | 4 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Dentaurum GmbH & Co. KGDENTAURUM GMBH&CO.KG | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dentaurum GmbH & Co. KG | 1 | — | 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 Dentaurum GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Crozat Special wireCrozat wireDentaflexdentaflex arch wireDentaflex wireNoninium arch wireOrthorama arch wirerema Spee wireRemaloyremaloy wire 10 moreRemaniumremanium arch wireremanium steel ligature wireremanium wirerematitan "LITE" arch wirerematitan SPECIAL arch wirerematitan SPECIAL wirerematitan wireTensic arch wireTranslucent Ideal Arch pearl | 1980 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | ConTecConTec LCConTec LCRConTec SENO-MIX BondingSmartBond | 2011 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | DentalasticsDentalastics plastic ligatureDentalastics separatorElasto-Force plastic chainIntraoral latex elasticsmagic SUPER Elasto-Force plastic chainSUPER Elasto-Force plastic chain | 1981 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | CarmenCarmen CCS Compact Ceramic SystemceraMotionceraMotion LiSiceraMotion One Touchn!ceTriceram | 2009 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | dinamique c bracketdinamique m bracketdiscovery bracketdiscovery pearldiscovery pearl bracketdiscovery SL 2 bracketdiscovery SL bracketdiscovery smart bracketdiscovery starequilibrium 2 bracket 9 moreequilibrium bracketequilibrium mini bracketequilibrium ti bracketFascinationFascination 2Fascination 2 bracketFascination bracketMetal brackettopic bracket | 1980 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | amda Advanced Molar Distalization ApplianceExpansion screw for progenia activator acc. to WeiseExpansion screw for split activatorExpansion screw key largeExpansion screw key smallExpansion screw Mini / Medium / Maxi / MagnumFan type expansion screwFlexible forward thrust double plate system acc. to SchanengHerbst IHerbst II 22 moreHerbst IVHerbst TSMandibular bow screw acc. to MuellerNEO BertoniNeo-VDPpalexpalex clickpalex neoprime4me® RETAIN3Rrematitan Expansion screw Mediumrematitan-Expansion screw MediumRetraction screw Extra Mini / Mini / MediumSectional screw MediumSectional screw MiniSUS2 Sabbagh Universal SpringSUS3 Sabbagh Universal SpringThree dimensional screw acc. to Bertoni / SteinerTitanium palexVarietyVariety clickVariety SPVariety SP click | 1980 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Band material | 1980 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Separators | 1981 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | Translucent Ideal Arch pearl | 2014 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Tomas-drill | 2010 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | Face maskHigh-pull headgearReverse-pull headgearUniversal-pull headgearVertical-pull headgear | 2010 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | BuccalBuccal tubeOrthoOrtho buccal tubeOrtho-Cast buccal tubeOrtho-Cast mini buccal tubeOrtho-Cast NF buccal tubeOrtho-Cast sl buccal tuberematitan buccal tubeStandard 1 moreStandard buccal tube | 1980 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | discovery pearl debonding instrumentDistal end benderDistal end bender, double endedLigatorLigature adapterLigature adapter, double endedLinguBallScalerScaler, double endedScrew driver 1 moreSL-Instrument | 1981 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Bar hingeBar sleevedent attachJacket Crown PostsRoot Posts | 2010 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | dentaformdentaform banddentaform Snap bandStandard bandStandard bands | 1981 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | ClampSliding tubeWire Orthodontic | 1981 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Piston springPiston spring screwPreformed SpringSpringTension and Compression springTension/Compression spring | 1980 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Lister | LigatorLigature adapterLigature tucking instrument | 1980 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | AlignerBracketPlastic jig aligner | 1981 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Band seaterBand setterMolar band seater | 1980 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Eby band setterMershon Band Pusher | 1980 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Lister | Eby band seater | 1980 |
| Disk GuardEEJ · Class 1 | — | Maker | Face formerOral Screen "Ulmer Model"OrthoSafe | 2010 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Clamping tweezersmagic mosquito forcepsMosquito forceps | 2010 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Flexaponal special waxGumex NModeling waxProtection waxThermo waxWax Dental | 1981 |
| All Precision AttachmentEGG · Class 1 | — | Maker | AttachmentLingual buttonLingual hookMesh basePrecision attachmentTitanium direct bond pad | 1981 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Corundum discDiasint Diamond discDisk Abrasive | 1986 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Ultrasonic cleaning solution | 2010 |
| Preformed BarEHO · Class 1 | — | Maker | Lingual barremanium palatal barremanium Quad Helix | 1986 |
| Preformed ClaspEHP · Class 1 | — | Maker | ClaspClasp PreformedNoninium claspNoninium labial archremanium arrow anchorremanium clasp | 1981 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | O-Tray impression trays"O" TRAYS | 1980 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Lip rectractor | 2010 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Bracket positioning gaugeDepth | 1986 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Molar band seaterSeparating strip holder | 2010 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | remanium 2000+remanium 2001remanium CS+remanium CSeremanium G-softremanium GM 380+remanium GM 800+remanium GM 900remanium LFCremanium secura 10 moreremanium starremanium star CLremanium star MD Iremanium Star MDIIrematitanrematitan CLrematitan Mrematitan TI2rematitan TI5Tritan | 1986 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BurBur for acrylicsGrindingLaboratory burs for plasticsPolishingSilicon PolisherSuper hard metal burTrimming | 1981 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | Chamois leather polishing brushCloth polishing brush | 2010 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | DentAurum BioDentAurum ClassicDentAurum LFC | 1981 |
| Wire ClaspEJW · Class 1 | — | Maker | Clasp wire | 1981 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | Reamer | 2010 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | OrthalgenatOrthalgenat DuoOrthalgenat Ex | 2010 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | tomas-punch | 2010 |
| Periodontic MarkerEMP · Class 1 | Dental hand instruments | Maker | tomas-X marker | 2010 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Contouring pliersCrimping pliersHow pliersLigature Forming pliersLoop Forming pliersOrthodontic pliersTweed pliersWeingart Universal pliersWire Bending pliers | 1980 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Face bowFace bowsFace maskNoninium face bowStandard face bow | 1981 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | OrthocrylOrthocryl black & whiteOrthocryl Color concentrateOrthocryl Disco glitterOrthocryl EQOrthocryl Neon | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | tomas PItomas RPE eyelettomas TADmatchtomas-abutment plain / EPtomas-abutment tubetomas-abutment universaltomas-abutment wiretomas-applicatortomas-auxiliary kit 18 / 22tomas-torque ratchet 2 moretomas-transfer captomas-wheel | 2010 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | tomastomas pin | 2010 |
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
Dentaurum GmbH & Co. KG 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: Dentauraum, Inc. (6), Dentaurum (4), Biomers Product, LLC (1), Gac Intl., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 May 2008 | K081143 | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | Biomers Product, LLC | DYW Orthodontic Plastic Bracket |
| 15 Apr 2005 | K042965 | TOMAS PIN | Dentaurum | OAT Orthodontic Endosseous Implant |
| 21 Nov 2003 | K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | Dentaurum | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 5 Jun 2001 | K011428 | TRICERAM | Dentaurum | EIH Porcelain Powder |
| 5 Jun 2001 | K011425 | CARMEN | Dentaurum | EIH Porcelain Powder |
| 5 Apr 1999 | K981036 | SMARTBOND | Gac Intl., Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 13 Feb 1995 | K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. | KMY Preformed Tooth Positioner |
| 10 Aug 1994 | K942666 | ORTHALGENAT IMPRESSION MATERIAL | Dentauraum, Inc. | ELW Impression Material |
| 1 Aug 1994 | K936151 | EXTRAORAL HEADGEAR | Dentauraum, Inc. | DZB Orthodontic Extraoral Headgear |
| 4 Feb 1994 | K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. | EJF Orthodontic Metal Bracket |
| 4 Feb 1994 | K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Dentauraum, Inc. | ECI Orthodontic Elastic Band |
| 4 Feb 1994 | K935140 | DENTAURUM STEEL LIGATURE WIRES | Dentauraum, Inc. | DZC Orthodontic Wire |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dentaurum GmbH & Co. KGFDA reg. 9611458 | ISPRINGEN Baden-Wurttemberg, Germany | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010391). 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.