FDA Registration Active 🇩🇪 Germany

Dentaurum GmbH & Co. KG

Reg #: 9611458 · FEI: 3002809532 · Expires 2026
Products
49
Proprietary Names
269
Establishment Types
2
Classifications
49

Registration Details

Registration Name
Dentaurum GmbH & Co. KG
Registration Number
9611458
FEI Number
3002809532
Status
Active
Expiry Year
2026
Initial Importer
No
Address
TURNSTRASSE 31
City
ISPRINGEN Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K942666

Owner / Operator

Firm Name
Dentaurum GmbH & Co. KG
Operator Number
8010391
Address
Turnstrasse 31
City
Ispringen
State
Baden-Wurttemberg
Postal Code
75228
Country
DE
Correspondent
Eda Kaya

US Agent

Business Name
Dentaurum, Inc.
Contact Name
Thomas Rehorst
Address
2050 Cabot Boulevard West, Suite 100
City
Langhorne
State
PA
ZIP
19047
Country
US
Phone
267 6890017

Products

Device Name Product Code
Alloy, Other Noble Metal EJS
Facebow KCR
Band, Elastic, Orthodontic ECI
Tube, Orthodontic DZD
Setter, Band, Orthodontic ECR
Instrument, Ligature Tucking, Orthodontic ECP
Material, Impression ELW
Wire, Orthodontic DZC
Guard, Disk EEJ
Gauge, Depth, Instrument, Dental EIL
Retractor, All Types EIG
Marker, Periodontic EMP
Attachment, Precision, All EGG
Reamer, Pulp Canal, Endodontic EKP
Strip, Polishing Agent EHM
Tray, Impression, Preformed EHY
Bracket, Metal, Orthodontic EJF
Driver, Band, Orthodontic ECT
Powder, Porcelain EIH
Cutter, Wire HXZ
Retainer, Screw Expansion, Orthodontic DYJ
Clamp, Wire, Orthodontic ECN
Clasp, Preformed EHP
Band, Preformed, Orthodontic ECM
Pusher, Band, Orthodontic ECS
Adhesive, Bracket And Tooth Conditioner, Resin DYH
Spring, Orthodontic ECO
Pin, Retentive And Splinting, And Accessory Instruments EBL
Maintainer, Space Preformed, Orthodontic DYT
Band, Material, Orthodontic DYO
Wax, Dental, Intraoral EGD
Accessories, Implant, Dental, Endosseous NDP
Bar, Preformed EHO
Handle, Instrument, Dental EJB
Forceps, Dressing, Dental EFL
Bracket, Plastic, Orthodontic DYW
Drill, Dental, Intraoral DZA
Headgear, Extraoral, Orthodontic DZB
Wheel, Polishing Agent EJQ
Punch, Biopsy, Surgical EME
Bur, Dental EJL
Positioner, Tooth, Preformed KMY
Implant, Endosseous, Orthodontic OAT
Alloy, Metal, Base EJH
Aligner, Bracket, Orthodontic ECQ
Disk, Abrasive EHJ
Plier, Orthodontic JEX
Instruments, Dental Hand DZN
Clasp, Wire EJW

Proprietary Names

DentAurum LFC DentAurum Bio DentAurum Classic Noninium face bow Face mask Face bow Face bows Standard face bow Dentalastics plastic ligature magic SUPER Elasto-Force plastic chain Elasto-Force plastic chain Dentalastics separator SUPER Elasto-Force plastic chain Dentalastics Ortho-Cast buccal tube Ortho Ortho buccal tube Ortho-Cast NF buccal tube rematitan buccal tube Buccal tube Standard Ortho-Cast sl buccal tube Ortho-Cast mini buccal tube Buccal Standard buccal tube Band setter Band seater Molar band seater Ligature adapter Ligator Ligature tucking instrument Orthalgenat Duo Orthalgenat Ex Orthalgenat remanium steel ligature wire dentaflex arch wire rematitan SPECIAL arch wire remanium arch wire Orthorama arch wire rematitan "LITE" arch wire Tensic arch wire Noninium arch wire OrthoSafe Face former Oral Screen "Ulmer Model" Depth Bracket positioning gauge Lip rectractor tomas-X marker Mesh base Lingual hook Titanium direct bond pad Lingual button Attachment Precision attachment Reamer Ultrasonic cleaning solution "O" TRAYS O-Tray impression trays discovery bracket equilibrium mini bracket equilibrium bracket discovery smart bracket discovery SL bracket Metal bracket discovery SL 2 bracket equilibrium 2 bracket equilibrium ti bracket topic bracket dinamique m bracket discovery star Eby band seater ceraMotion Carmen n!ce Carmen CCS Compact Ceramic System ceraMotion LiSi ceraMotion One Touch Wire Cutter Side Cutter Flush Cutter Distal Cutter Ligature Cutter Expansion screw for split activator SUS2 Sabbagh Universal Spring Herbst II Expansion screw for progenia activator acc. to Weise Sectional screw Medium Titanium Palex Flexible forward thrust double plate system acc. to Schaneng Variety SP Expansion screw Mini / Medium / Maxi / Magnum Fan type expansion screw Herbst IV amda Advanced Molar Distalization Appliance Sectional screw Mini Palex Mandibular bow screw acc. to Mueller rematitan-Expansion screw Medium Herbst TS Variety rematitan Expansion screw Medium Retraction screw Extra Mini / Mini / Medium Three dimensional screw acc. to Bertoni / Steiner Herbst I SUS3 Sabbagh Universal Spring Variety click palex click palex Titanium palex Variety SP click Neo-VDP Expansion screw key small Expansion screw key large NEO Bertoni palex neo prime4me® RETAIN3R Wire Orthodontic Sliding tube Clamp remanium clasp Noninium labial arch Clasp Preformed Clasp Noninium clasp remanium arrow anchor dentaform band Dentaform Standard band dentaform Snap band dentaform Standard bands Eby band setter Mershon Band Pusher Fascination Fascination 2 Fascination 2 bracket dinamique c bracket discovery pearl bracket discovery pearl Fascination bracket SmartBond ConTec LC NO-MIX Bonding ConTec SE ConTec ConTec LCR Tension and Compression spring Tension/Compression spring Piston spring screw Piston spring Preformed Spring Spring Jacket Crown Posts Bar hinge Root Posts dent attach Bar sleeve Separators Band material Protection wax Wax Dental Modeling wax Gumex N Flexaponal special wax Thermo wax tomas-abutment wire tomas-wheel tomas-abutment universal tomas-auxiliary kit 18 / 22 tomas-transfer cap tomas-abutment tube tomas-torque ratchet tomas-abutment plain / EP tomas-applicator tomas RPE eyelet tomas TADmatch tomas PI Remaloy Crozat wire Dentaflex wire Crozat Special wire remaloy wire Dentaflex rematitan SPECIAL wire remanium wire rematitan wire Remanium rema Spee wire Intraoral latex elastics remanium Quad Helix remanium palatal bar Lingual bar Separating strip holder Clamping tweezers magic mosquito forceps Mosquito forceps Translucent Ideal Arch pearl Tomas-drill tomas-drill Vertical-pull headgear Universal-pull headgear Reverse-pull headgear High-pull headgear Chamois leather polishing brush Cloth polishing brush tomas-punch Polishing Laboratory burs for plastics Bur for acrylics Trimming Bur Grinding Super hard metal bur Silicon Polisher Orthocryl EQ Orthocryl Disco glitter Orthocryl black & white Orthocryl Orthocryl Color concentrate Orthocryl Neon tomas pin tomas remanium GM 800+ remanium G-soft Tritan rematitan M remanium star remanium secura remanium 2001 remanium LFC remanium GM 380+ remanium CSe remanium GM 900 remanium 2000+ remanium star MD I remanium CS+ remanium Star MDII rematitan TI5 rematitan TI2 rematitan CL rematitan remanium star CL Triceram Aligner Bracket Plastic jig aligner Disk Abrasive Corundum disc Diasint Diamond disc Wire Bending pliers Tweed pliers Orthodontic pliers How pliers Contouring pliers Crimping pliers Loop Forming pliers Weingart Universal pliers Ligature Forming pliers Distal end bender discovery pearl debonding instrument Ligature adapter, double ended LinguBall Scaler SL-Instrument Screw driver Scaler, double ended Distal end bender, double ended Clasp wire

Establishment Types

Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device