Apoza

FDA UDI

Class II (US FDA UDI)

by Apoza Enterprise Co., Ltd.

Identity

Trade Name: APOZA FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: LED CURING LIGHT: 5W. FDA UDI
Model / Reference: TOP Light Plus FDA UDI
Description: LED CURING LIGHT: 5W. FDA UDI

Identifiers

Primary DI / UDI-DI: 04719883751454 FDA UDI
510(k) Number: K041303 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/surgical polymerization lamp

Apoza by Apoza Enterprise Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental/surgical polymerization lamp.

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WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
VALO — ULTRADENT PRODUCTS, INC. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
VALO — ULTRADENT PRODUCTS, INC. · Class II
Coltolux — Coltene/Whaledent Inc. · Class II
Ascent PX Charging Station — CAO GROUP, INC. · Class II

Cleared under the same submission

K041303 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Apoza Enterprise Co., Ltd.

Sources (1)

FDA UDI 9ea719b4-1256-4d12-8338-bf2d411318ec 34 fields · synced Jun 8, 2026