Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611458

FEI Number

3002809532

Entity Name

Dentaurum GmbH & Co. KG

City/State/Country

ISPRINGEN Baden-Wurttemberg, DE

Establishment Address

TURNSTRASSE 31, ISPRINGEN Baden-Wurttemberg 75228, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dentaurum GmbH & Co. KG (Owner Number: 8010391)

Owner / Operator Contact Address

Turnstrasse 31, Ispringen, DE-BW 75228, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Molar band seater Clamping tweezers magic mosquito forceps Mosquito forceps Translucent Ideal Arch pearl Tomas-drill tomas-drill Vertical-pull headgear Universal-pull headgear Face mask Reverse-pull headgear High-pull headgear Chamois leather polishing brush Cloth polishing brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	1981-01-27
KCR	Facebow	Dental	Class 1	872.3220	1981-01-27
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	1981-01-27
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	1980-09-02
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	1980-09-02
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	1980-09-02
ELW	Material, Impression	Dental	Class 2	872.3660	2010-01-05
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2010-01-12
EEJ	Guard, Disk	Dental	Class 1	872.6010	2010-01-19
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	1986-06-09
EIG	Retractor, All Types	Dental	Class 1	872.4565	2010-11-15
EMP	Marker, Periodontic	Dental	Class 1	872.4565	2010-10-18
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	1981-01-27
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2010-11-01
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2010-01-14
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1980-09-02
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	1980-09-02
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	1980-09-02
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2009-12-15
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2013-01-25
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	1980-09-02
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	1981-01-27
EHP	Clasp, Preformed	Dental	Class 1	872.3285	1981-01-27
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	1981-01-27
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	1980-09-02
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2013-01-11
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-03-15
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	1980-09-02
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2010-01-14
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	1981-01-27
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	1980-09-02
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	1981-01-27
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2010-10-06
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	1980-09-02
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2010-01-12
EHO	Bar, Preformed	Dental	Class 1	872.3165	1986-06-09
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2010-10-06
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2010-10-06
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2014-01-27
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2014-01-27
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2010-10-11
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2010-06-10
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2010-10-11

Official Correspondent

Eda Kaya

US Agent Details

Thomas Rehorst Business: Dentaurum, Inc. Email: trehorst@dentaurum-us.com Phone: (267) 6890017

Related Public Records

Same Entity

Dentaurum GmbH & Co. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611458. Last updated year: 2026. Please use registration number 9611458 when referencing this establishment in official correspondence.