Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007284437

FEI Number

3007284437

Entity Name

ORTHO ARCH COMPANY INC

City/State/Country

Schaumburg, IL, US

Establishment Address

1107 Tower Road, Schaumburg, IL 60173, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ORTHO ARCH COMPANY INC (Owner Number: 10030081)

Owner / Operator Contact Address

1107 Tower Road, Schaumburg, IL 60173, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cottonmouth Dry Field System Root Canal Files Constant Force Nitinol Spring GTS Springs Mini-Molds CUTTER, WIRE Patient Care Kits, Travel Toothbrush, Disposable Toothbrush Composite Direct Bond Button Lingual Sheaths, Lingual Cleats (Weldable and Direct Bond) Crimpable Hook Coated COMPOSITE DIRECT BOND BUTTON Turbo-8 Braid SE Niti Black Satin SE Niti HA Niti with Copper SS Nic-O-Loy Keyhole 4-Loop Retraction Arch, SS T-Loop Retraction Arch, Beta-Titanium Mushroom-Loop Retraction Arch Pre-Torqued SE Niti HA Niti Finishing Performed Ligature Wire, Toothtone Ligature Wire, Shorty Ligature Ties, Kobyashi Tie Hooks D2 Appliance Posted SS Archwire, SS Cuspid-Loop Retraction Arch, AJ Wilcock Vertical-Loop Retraction Arch Shorty Kobyashi Hooks Stainless Steel, SS Multi-Stranded Leveling, SS Keyhole 2-Loop Retraction Arch, SS Keyhople 4-Loop Retraction Arch Multi Modulus (Multi-Force) HA Niti Heat Activated Niti SE Nitinol Wire Beta Titanium AJ Wilcock Australian Wire 25" Spool and 14" Length Wire Reverse Curve of Spee SE Niti and RSC (Straight Leg) SE Niti Brehm Niti Utility Arch Nano Coated Super Elastic Nitinol Archwires Super Glass Mirror: Occlusal, Lingual and Buccal Patient Care Kits Disposable Mirrors EZ Out Elevators Fusion Curing Light REDI SET LED LIGHT IPR Patient Relief Wax Patient Care Kits Patient Relief Wax Arch Markers SLB Easy Opening Instrument Buccal Tubes Pin & Ligature Cutter, Mini Ligature Cutter Photo Lip Retractor, Double Ended Lip Retractor, Expando Cheek Retractor, Access Cheek Retractor, Lip Retractor Glide-Ties, Elastic Chains, Elastomeric Separators Elastomeric Tissue Guard, Elastomeric Thread & Tubing, Rotation Wedges Amber Interoral Elastics, Rainbow Interoral Elastics, Non-Latex Clear Interoral Elastics Aligner Scissors Sport Mouthguard Elastic Attachers, Band Pusher, Band Seater

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2018-10-19
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2024-05-24
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2017-07-21
KXR	Applicator, Resin	Dental	Class 1	872.3140	2017-06-02
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2023-04-26
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2017-07-25
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2017-07-21
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2017-10-13
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2017-07-21
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2017-07-25
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2017-08-14
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2017-08-14
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2021-03-02
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2017-06-09
EMP	Marker, Periodontic	Dental	Class 1	872.4565	2017-07-21
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2017-07-21
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2017-07-21
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2017-06-06
EIG	Retractor, All Types	Dental	Class 1	872.4565	2019-02-27
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2017-07-21
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2026-02-09
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2019-09-04
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2017-07-24

Official Correspondent

Jonathan Leng

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHO ARCH COMPANY INC

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007284437. Last updated year: 2026. Please use registration number 3007284437 when referencing this establishment in official correspondence.