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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
LED TURBO FDA UDI
Description
LED CURING LIGHT: 5W. FDA UDI

Identifiers

Primary DI / UDI-DI
04719883751379 FDA UDI
510(k) Number
K040618 FDA UDI
FDA Product Code
EBZ FDA UDI
EEG FDA UDI
GMDN Term
Dental/surgical polymerization lamp FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6070 FDA UDI
872.6475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/surgical polymerization lampTooth-bleaching acceleration unit

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

Similar devices

Also classified as Tooth-bleaching acceleration unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 37c2fb5b-20d1-4d7f-ab6f-8ced95f3dd6b 34 fields · synced May 31, 2026