Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034278341

FEI Number

3034278341

Entity Name

ORTHONE INC.

City/State/Country

Wilmington, DE, US

Establishment Address

300 Delaware Ave Suite 210 2207 Wilmington De 19801, Wilmington, DE 19801, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Orthone INC. (Owner Number: 10092184)

Owner / Operator Contact Address

300 Delaware Avenue, Suite 210-2207, Wilmington, DE 19801, Wilmington, DE 19801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

orthone, Forceps, Dental Tweezers orthone orthone, Toothpaste orthone orthone, Orthodontic wax, Orthodontic Wax orthone orthone, Orthodontic Indirect Bonding Tray, OBRACE GUIDE orthone orthone, Orthodontic Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2024-12-12
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-12-12
JES	Floss, Dental	Dental	Class 1	872.6390	2025-12-25
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2024-12-12
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-12-12
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2024-12-12
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2025-12-25
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-12-12
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2025-12-25

Official Correspondent

Anita Ke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orthone 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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.

Similar Registrations

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3008346537	CANGZHOU LANKANG MEDICAL INSTRUMENTS DEVELOPING CO., LTD.	Cangzhou Hebei, CN
3026326493	ZHEJIANG YAMEI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Yang Jiao Lang Zin'an Town Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034278341. Last updated year: 2026. Please use registration number 3034278341 when referencing this establishment in official correspondence.