Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680864

FEI Number

1000493876

Entity Name

APOZA ENTERPRISE CO., LTD.

City/State/Country

Hsin-Chuang District New Taipei, TW

Establishment Address

6F, NO.657, Chung-Cheng Road, Hsin-Chuang District New Taipei 24257, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

APOZA ENTERPRISE CO. LTD (Owner Number: 9012024)

Owner / Operator Contact Address

6F, NO.657, Chung-Cheng Road, Hsin-Chuang District, TW-NWT 24257, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070373

PMA Number

N/A

All Registered Proprietary Names

LED Turbo Pen ; TOP Light Turbo ; TOP Light plus; TOP Light ; Megalight Turbo ; LED 10W ; Mega light CL BT COOL;BT COOL (plus) ; BT COOL Easy Oral Camera; CAM-Ⅰ; CAM-Ⅱ Light, fiber Optic, Dental GP Series APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2003-08-01
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2004-10-20
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2012-02-07
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	1994-11-30
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2014-07-29
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2003-08-01

Official Correspondent

Ying Chieh Hsu

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

APOZA ENTERPRISE 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
K831824	Silverman'S	DENTAL ELECTRONIC/S.B.R TRADING BU HAND	1983-08-11

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3030126955	ONVET MEDICAL CANADA INC	TORONTO Ontario, CA
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680864. Last updated year: 2026. Please use registration number 9680864 when referencing this establishment in official correspondence.