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 UDIEEG FDA UDI
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6070 FDA UDI872.6475 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
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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 37c2fb5b-20d1-4d7f-ab6f-8ced95f3dd6b 34 fields · synced May 31, 2026