AMERICAN ORTHODONTICS

FDA Device Registration & Listing · SHEBOYGAN, WI, US · Registration 2126683

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2126683
FEI Number
2126683
Entity Name
AMERICAN ORTHODONTICS
City/State/Country
SHEBOYGAN, WI, US
Establishment Address
3524 Washington Ave, SHEBOYGAN, WI 53081, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
AMERICAN ORTHODONTICS (Owner Number: 2126683)
Owner / Operator Contact Address
3524 Washington Avenue, --, Sheboygan, WI 53081, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Kilroy Spring Ulysses/Extrusion Spring Stainless Steel Springs Auxiliary Light Torquing Arch Nickel Titanium Memory Springs NiTi Springs Rotation Spring Compliance Spring Separating Spring Uprighting Spring Warren ART® Auxiliary Spring Porcelain Conditioner Band Material Orthodontic Wax Laminated Bite Wafers Debond Wafers Ortho Wax Bites Eagle Spectrum™ Eagle FluorSure Eagle No Drift™ Rollo Bands Mini Skirt Crowns MR Anteriors Contoured MRX Bands MR1 MR2 Master Series Slim Tube Inconel iFit Empower LP Low Profile Mini Master Series Nola Buccal Tube Empower 2 Dr. Korn Tube Convertible Singel Funneled Entrance Non Convertible Triple DB Tube Gold Convertible Triple PIggyback Tubes Non Convertible Lip Bumper Convertible Double Non Convertible WRAPAROUND Cross Tubes Non Convertible Non Convertible Double Iconix BracePaste Prime Plus Tanzo Ball Retainer Clasps Ligature Wire Beta Titanium Wire Everwhite Wire Force Two NiTi Wire Wrap Around Hawley Retainer Multiphase Blue Chromium Cobalt Wire Stainless Steel Wire Tritanium Therma-Ti Superelastic Titanium Memory Stainless Steel Retainer Wire Kobayashi Hooks Orientation Pin Therma-Ti "D" Therma-Ti Lite Power Pin Stainless Steel Multi-Strand NT3 Iconix Platypus Orthodontic Flosser Impressa/Chrome™ Bandtite Glass Ionomer Cement 300 Series Facebows Acid Etching (Gel, Semi-Gel, Liquid) EAGLEWEAR; Radiance Plus® BracePaste Fluoride Sealant Bandtite™ Band Cement Acid Etchant Ligating Instruments(Ligature Director, Single End Explorer, Force Module Separator, Ligature Tying Pliers, Wire Seater) Ligating Instruments (Mathieu Needle Holder, Smaha Forceps, Hemostat) No Mix: 30™ Impressa/Sure™ Carbide Bur Bur Kit Diamond Bur Empower Clear®, Empower® 2 Clear BracePaste Band And Build LC Impression Tray Tongue Director Bite Blocks Bondable Space Maintainer Bondable Retainer MR Lock LC™ Band Slitting Instrument Empower Instrument Specialty Instruments (Band Seater/Cement Scaler) Specialty Instruments (Adhesive Remover) Specialty Instruments (Wire Cutter) Bracket & Band Placing Instrument (Direct Bond Bracket Holders, Band Seater) AO Instruments - Open/Closer AO Instruments - Scaler, Band Pusher Specialty Instruments (Mouth Mirror) Specialty Instruments (Bracket Placement Guide) Luno™ (Debond) Bracket & Band Placing Instrument (Band Pusher) Specialty Instruments (Convertible Cap Remover, Spatula) Bracket & Band Placing Instrument (High Heat Bite Stick, Tweezers) Hex Head Driver 20/40 Ceramic Brackets™ (Roth, McLaughlin-Bennett-Trevisi (MBT), Standard Edgewise) Mini Master Series Stealth Lingual T3 LP Low Profile Forever Gold 24K Forever Gold Metal Custom Rx Master Series Mini Tweed Mini Standard Edgewise Empower 2 Iconix SL Stainless Steel Bracket atmos® material - tooth positioner, Vero BracePaste Bracepaste - Color Change Ultra-Guard Mouthguard Specialty Instruments (Boone Gauge) Specialty Instruments (Force Gage) The Wildlife Series Clear Rotation Wedges E-Z Tie Tubing Plastic Tie Sea Life Elastics Arch Wire Sleeve Memory Chain Tubing Separators Colored Chain Ligatures Elastic Placers Textured Thread Wire Bending Pliers Luno (Cutters, Band Remover) Luno (Pliers)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ECO Spring, Orthodontic Dental Class 1 872.5410 1992-07-13
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2013-11-04
DYO Band, Material, Orthodontic Dental Class 1 872.5410 1992-07-13
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2013-07-25
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2013-11-04
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 1992-07-13
DZD Tube, Orthodontic Dental Class 1 872.5410 1992-07-13
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2026-06-12
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2026-06-12
DZC Wire, Orthodontic Dental Class 1 872.5410 1992-07-13
JES Floss, Dental Dental Class 1 872.6390 2022-12-08
ELW Material, Impression Dental Class 2 872.3660 2019-02-13
EMA Cement, Dental Dental Class 2 872.3275 2007-11-08
KCR Facebow Dental Class 1 872.3220 1988-09-26
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-12-09
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2020-02-25
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2013-07-03
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2024-09-25
EMA Cement, Dental Dental Class 2 872.3275 2013-11-04
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2018-05-30
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2013-07-03
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-11-08
ELW Material, Impression Dental Class 2 872.3660 2011-10-14
EJL Bur, Dental Dental Class 1 872.3240 2015-12-08
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2013-07-03
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2020-08-17
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2001-08-08
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 1992-07-13
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2013-11-04
DZN Instruments, Dental Hand Dental Class 1 872.4565 2013-07-03
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2013-07-03
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 1992-07-13
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 1993-01-15
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2016-10-20
BRW Protector, Dental Anesthesiology Class 1 868.5820 2014-02-14
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 1993-01-15
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 1992-07-13
JEX Plier, Orthodontic Dental Class 1 872.4565 1992-07-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERICAN ORTHODONTICS
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
K161684 Reliance Orthodontic Products, Inc. Quantum LB 2016-10-06
K810210 Sci-Pharm, Inc. MAGIC-TOUCH 1981-02-10
K875144 Reliance Orthodontic Products, Inc. EXCEL FAST SET 1988-02-26
K020499 Jeneric/Pentron, Inc. BOND-3 ADHESIVE 2002-04-22
K801093 Dentsply Intl. PRISMA-BOND 1980-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
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 307850***DISTRIBUTED 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 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2126683. Last updated year: 2026. Please use registration number 2126683 when referencing this establishment in official correspondence.
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