BONART CO. LTD.

FDA Device Registration & Listing · KEELUNG, TW · Registration 9710363

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
9710363
FEI Number
3008981576
Entity Name
BONART CO. LTD.
City/State/Country
KEELUNG, TW
Establishment Address
NO.80, WUXUN STREET, ANLE DISTRICT, KEELUNG 20446, TW
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BONART CO. LTD. (Owner Number: 9039893)
Owner / Operator Contact Address
NO. 80, WUXUN STREET, ANLE DISTRICT, KEELUNG, TW-KEE 20446, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K052028
PMA Number
N/A

All Registered Proprietary Names

ART-E1 ELECTROSURGERY UNIT Bonart (ART) Dental Handpieces, Disposable Prophy Angle (PROFORMANCE) & Accessories ARTEOTOMY-OM1/OP1 ULT.SURGERY SYS. ART-L3 LED CORDLESS CURING LIGHT ART-P6 PIEZOELECTRIC SCALER ART-P3II / M3II PRO MULTI FUNCTION ART-M1 MAGNET ULTRASONIC SCALER ART-P3II/P4 PIEZOELECTRIC SCALER ART-L2 HALOGEN LIGHT CURING UNIT ART-M3II MAGNET ULTRASONIC SYSTEM ART-M4 MAGNET ULTRASONIC SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKZ Unit, Electrosurgical, And Accessories, Dental Dental Class 2 872.4920 2007-10-18
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2017-08-10
DZI Drill, Bone, Powered Dental Class 2 872.4120 2008-09-04
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2007-10-18
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-10-26
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-09-04
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-10-18
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-10-18
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2007-10-18
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2001-06-22

Official Correspondent

BANKSON TSAI

US Agent Details

Hui Chin Liao Business: Magpie Tech Corp. Email: liao@askmagpie.com Phone: (626) 6005330

Related Public Records

Same Entity

BONART CO. LTD.
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
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
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710363. Last updated year: 2026. Please use registration number 9710363 when referencing this establishment in official correspondence.
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