Identity
- Trade Name
- APOZA FDA UDI
- Generic Name
- Dental abrasive air jet system FDA UDI
- Device Name
- PROPHY APII is designed to clean extrinsic stains caused by tobacco, tea, coffee or food on tooth surfaces by using sodium bicarbonate. The air and water are supplied from dental unit. FDA UDI
- Model / Reference
- PROPHY APII FDA UDI
- Description
- PROPHY APII is designed to clean extrinsic stains caused by tobacco, tea, coffee or food on tooth surfaces by using sodium bicarbonate. The air and water are supplied from dental unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719883751102 FDA UDI
- 510(k) Number
- K033198 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental abrasive air jet system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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 abrasive air jet system
Apoza by Apoza Enterprise Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K033198 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 005372e3-b552-4bf7-86e3-c92d7bfbd5b6 34 fields · synced Jun 8, 2026