Identity
- Trade Name
- PWR Pair FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- PWR Pair Combo Unit FDA UDI
- Model / Reference
- APPAIR FDA UDI
- Description
- PWR Pair Combo Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889950142551 FDA UDI
- 510(k) Number
- K231391 FDA UDI
- FDA Product Code
- KOJ FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6080 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic dental scaling/debridement system
PWR Pair by Hu-Friedy Mfg Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231391 also covers:
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- PWR Handpiece — HU-FRIEDY MFG CO., LLC
- PWR Handpiece — HU-FRIEDY MFG CO., LLC
- PWR Handpiece — HU-FRIEDY MFG CO., LLC
- Subgingival PWR Perio Tips — HU-FRIEDY MFG CO., LLC
- MECTRON — MECTRON SPA
- MECTRON — MECTRON SPA
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
- Hu-Friedy Mfg Co., Llc
Sources (1)
- FDA UDI 48d5883d-6958-44c4-8b22-885510f711b6 35 fields · synced May 31, 2026