POWERMAX 25 - Powermax 25, Model Pm25
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051547 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
- Models / Variants
- Powermax 25, Model Pm25 FDA 510(k)Powermax 30, Model Pm30 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PowerMax Ultrasonic Scaler, Models PM25 and PM30, is a dental ultrasonic scaler designed for scaling and root planing. It uses ultrasonic vibrations to effectively remove dental plaque and calculus from teeth surfaces, supporting periodontal health and oral hygiene. This device is classified under the FDA’s Class II category, ensuring it meets stringent safety and performance criteria for dental instruments.
The PowerMax Ultrasonic Scaler is intended for use in dental settings by trained professionals. These models are reusable and require proper cleaning and sterilization procedures to maintain functionality and safety. The device is not MRI-compatible and should be used in non-MRI environments. Models PM25 and PM30 have received FDA 510(k) clearance (K051547) and comply with the regulations outlined in 21 CFR 872.4850. Appropriate storage conditions are necessary to ensure device longevity and performance.
PowerMax Ultrasonic Scaler, Models PM25 and PM30
Frequently asked questions
What is the PowerMax Ultrasonic Scaler PM25/PM30 used for?
The PowerMax Ultrasonic Scaler, Models PM25 and PM30, is designed specifically for dental scaling and root planing. It uses ultrasonic vibrations to efficiently remove dental plaque and calculus from tooth surfaces, helping to maintain periodontal health and improve oral hygiene. This process is essential for preventing gum disease and supporting overall dental wellness.
How are the PowerMax PM25 and PM30 models supplied and prepared for use?
The PowerMax Ultrasonic Scaler models PM25 and PM30 are reusable devices. After each use, they require thorough cleaning and sterilization to ensure safety and functionality. Proper maintenance is critical to prevent cross-contamination and to extend the device’s operational lifespan. Follow manufacturer guidelines for cleaning protocols and sterilization methods.
Are the PowerMax PM25/PM30 models single-use or reusable?
The PowerMax Ultrasonic Scaler models PM25 and PM30 are designed for reuse. They are intended to be cleaned and sterilized between uses to maintain hygiene and performance standards. This design aligns with typical dental practice protocols for reusable instruments.
What storage conditions are recommended for the PowerMax Ultrasonic Scaler?
The PowerMax Ultrasonic Scaler should be stored in a clean, dry environment, protected from moisture and extreme temperatures. Proper storage ensures the device remains functional and free from contamination. Avoid storing it in areas exposed to direct sunlight or high humidity, as these conditions can degrade performance over time.
Can the PowerMax Ultrasonic Scaler be used in an MRI environment?
No, the PowerMax Ultrasonic Scaler is not MRI-compatible. It should only be used in non-MRI environments to prevent interference or safety hazards. Always verify the room’s equipment compatibility before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 (K051547) — FDA 510 (k ..., Device Listing 1573169728 - FDA.report, TPC POWER MAX 25 USER MANUAL Pdf Download | ManualsLib, Dell PowerMax - Dell Technologies Partner Portal
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051547 | Class II | Active |
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Manufacturer
- Manufacturer
- Tpc Advanced Technology, Inc.
Sources (1)
- FDA 510(k) K051547 24 fields · synced Oct 1, 2026