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
- [email protected]
- Phone
- 267 6890017
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Alloy, Other Noble Metal | EJS | Class 2 | Dental | No | 1981-01-27 |
| Facebow | KCR | Class 1 | Dental | No | 1981-01-27 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 1981-01-27 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 1980-09-02 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 1980-09-02 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 1980-09-02 |
| Material, Impression | ELW | Class 2 | Dental | No | 2010-01-05 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2010-01-12 |
| Guard, Disk | EEJ | Class 1 | Dental | No | 2010-01-19 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 1986-06-09 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2010-11-15 |
| Marker, Periodontic | EMP | Class 1 | Dental | No | 2010-10-18 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 1981-01-27 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2010-11-01 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2010-01-14 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 1980-09-02 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 1980-09-02 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 1980-09-02 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2009-12-15 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2013-01-25 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 1980-09-02 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 1981-01-27 |
| Clasp, Preformed | EHP | Class 1 | Dental | No | 1981-01-27 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 1981-01-27 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 1980-09-02 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2011-03-15 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 1980-09-02 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2010-01-14 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 1981-01-27 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 1980-09-02 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 1981-01-27 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2010-10-06 |
| Bar, Preformed | EHO | Class 1 | Dental | No | 1986-06-09 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2010-10-06 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2010-10-06 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2014-01-27 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2010-10-11 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2010-06-10 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2010-10-11 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2010-10-06 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1981-01-27 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2010-01-12 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2010-02-19 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 1986-06-09 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 1981-01-27 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 1986-06-09 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 1980-09-02 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 1981-01-27 |
| Clasp, Wire | EJW | Class 1 | Dental | No | 1981-01-27 |
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