Data / Medical devices / United States / Orthodentalusa Corp.

Orthodentalusa Corp.: FDA-registered device maker in Weston, FL, United States, 2 510(k) clearances

Name: Orthodentalusa Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Orthodentalusa Corp. is registered with the FDA (registration 3007962015) in Weston, FL, United States. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 26, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007962015
Address: 1500 Weston Rd Ste 204, Weston, FL, United States, 33326
Owner or operator: ORTHODENTALUSA CORP. (10031414)
Roles: Repackager or relabeler
First device listed: April 14, 2015
Registered through: 2026
Brand names listed: KASO MEDICAL TECHNOLOGY Co., LTD, ORTHODENTALUSA CORP

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Bracket, Orthodontic	ECQ	1	Repackager or relabeler	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Repackager or relabeler	accessdata.fda.gov
Band, Material, Orthodontic	DYO	1	Repackager or relabeler	accessdata.fda.gov
Band, Preformed, Orthodontic	ECM	1	Repackager or relabeler	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Repackager or relabeler	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Repackager or relabeler	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Repackager or relabeler	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Repackager or relabeler	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Setter, Band, Orthodontic	ECR	1	Repackager or relabeler	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Repackager or relabeler	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Repackager or relabeler	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 26, 2013	K130410	DENTAL UNIT WITH CHAIR	EIA	Substantially Equivalent	Xianyang North West Medical Instrument (Group) Co.	accessdata.fda.gov
December 21, 2004	K033044	DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER	ELC	Substantially Equivalent	American Green Dent. Mfg, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 26, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.