CSY INTERNATIONAL LLC

FDA Device Registration & Listing · Rancho Cucamonga, CA, US · Registration 3016543896

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
3016543896
FEI Number
3016543896
Entity Name
CSY INTERNATIONAL LLC
City/State/Country
Rancho Cucamonga, CA, US
Establishment Address
6737 Palo Verde Pl, Rancho Cucamonga, CA 91739, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
CSY INTERNATIONAL LLC (Owner Number: 10062340)
Owner / Operator Contact Address
6737 Palo Verde Pl, Rancho Cucamonga, CA 91739, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

J&J ORTHODONTICS NIEVE CICADA J&J ORTHODONTICS J&J Orthodontics J&J Ortho J&J Orthodontics J&J Ortho J&J Orthodontics J&J Ortho Precisa Veloz J&J Ortho J&J Orthodontics Beacon Suave Sigilo Precisa II Dorada J&J Orthodontics J&J Ortho J&J ORTHODONTICS Claro J&J Ortho J&J Orthodontics NIEVE GNI J&J Orthodontics J&J Ortho J&J Orthodontics J&J ORTHODONTICS J&J ORTHODONTICS J&J Ortho J&J Orthodontics J&J Orthodontics J&J Ortho J&J ORTHODONTICS J&J ORTHODONTICS J&J Ortho J&J Orthodontics J&J Ortho J&J Orthodontics Caber J&J Orthodontics J&J Ortho J&J ORTHODONTICS J&J Ortho J&J Orthodontics J&J ORTHODONTICS J&J ORTHODONTICS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2021-06-15
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2022-10-20
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2020-01-14
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 2020-01-14
DZD Tube, Orthodontic Dental Class 1 872.5410 2020-01-14
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2020-01-14
ECO Spring, Orthodontic Dental Class 1 872.5410 2020-01-14
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2022-06-28
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2020-01-14
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2020-11-24
ECQ Aligner, Bracket, Orthodontic Dental Class 1 872.4565 2020-01-14
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2022-06-28
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2022-10-20
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2020-01-14
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 2020-01-14
EIG Retractor, All Types Dental Class 1 872.4565 2022-06-28
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2022-10-20
DZC Wire, Orthodontic Dental Class 1 872.5410 2020-01-14
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2020-01-14
ECT Driver, Band, Orthodontic Dental Class 1 872.4565 2020-01-14
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2022-10-20
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2020-01-14
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2022-10-27
KXR Applicator, Resin Dental Class 1 872.3140 2022-10-22

Official Correspondent

Xiang Yan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CSY INTERNATIONAL LLC
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
K180404 3M Healthcare 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 2018-03-16
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02
K894358 Ormco Corp. LUMINA ORTHODONTIC BRACKET 1989-09-15
K925012 American Orthodontics PLASTIC CHAIN 1993-09-13

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 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 3016543896. Last updated year: 2026. Please use registration number 3016543896 when referencing this establishment in official correspondence.
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