Identity
- Trade Name
- Athena Champion FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- Athena Champion Mini Head Handpiece, Push Button Type, High Speed, 4 Hole Connector FDA UDI
- Model / Reference
- AC5000M-4P FDA UDI
- Description
- Athena Champion Mini Head Handpiece, Push Button Type, High Speed, 4 Hole Connector FDA UDI
Identifiers
- Catalog Number
- AC5000M-4P FDA UDI
- Primary DI / UDI-DI
- 00302730001990 FDA UDI
- 510(k) Number
- K925678 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motorized handpiece/set, pneumatic
Athena Champion by Young Dental Manufacturing I, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Young Dental Manufacturing I, Llc
Sources (1)
- FDA UDI a88b7a7d-98bc-42af-becc-00c84495f0cb 36 fields · synced May 30, 2026