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Sign in to claim this brandMECTRON SPA
US
Last updated May 24, 2026
What MECTRON SPA makes
The company produces dental ultrasonic surgical systems and associated handpiece tips, including periodontal, endodontic, and hard-tissue variants. These devices are designed for surgical precision, scaling, debridement, and torque adjustment in dental procedures. Reusable torque wrenches for ultrasonic systems are also part of the portfolio.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does MECTRON SPA manufacture?
MECTRON SPA specializes in dental ultrasonic surgical systems and their associated components. This includes handpiece tips for surgical precision (such as periodontal and hard-tissue variants), ultrasonic scaling/debridement systems (including endodontic tips), and full ultrasonic surgical systems. The company also produces reusable torque wrenches designed for use with ultrasonic dental systems, ensuring precise torque control during procedures.
Where is MECTRON SPA based, and does it operate internationally?
MECTRON SPA is headquartered in the United States. While the company’s primary location is in the US, its devices may be distributed or used globally depending on regulatory compliance and market demand. The company’s focus is on dental ultrasonic systems, which are widely applicable in clinical settings worldwide.
Which regulatory registries or databases list MECTRON SPA’s devices?
MECTRON SPA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify and track specific models of ultrasonic dental systems and accessories. Listing in the UDI database is a requirement for Class I and Class II devices under FDA regulations.
How are MECTRON SPA’s devices classified under FDA regulations?
MECTRON SPA’s devices fall into two FDA classification categories: Class I and Class II. Class I devices are generally considered low-risk and typically require only general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the nature of the procedure it supports, such as ultrasonic scaling or surgical precision in dentistry.
What is the purpose of the ultrasonic surgical systems and handpiece tips produced by MECTRON SPA?
MECTRON SPA’s ultrasonic surgical systems and handpiece tips are designed for high-precision dental procedures, including scaling, debridement, and surgical interventions. Ultrasonic technology enables efficient removal of plaque and calculus, as well as precise cutting or shaping of hard dental tissues. The specialized tips (periodontal, endodontic, or hard-tissue) cater to specific clinical needs, while reusable torque wrenches ensure consistent performance during adjustments, enhancing both accuracy and patient care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- piezosurgery.us
- —
- —
- [email protected]
- Phone
- +1 6144594922
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 436664734
Catalogue (310)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mectron | P13 + K10 | FDA UDI | Class II | Active |
| Mectron | PD0328B -US- | FDA UDI | Class II | Active |
| Mectron | P12 + K10 | FDA UDI | Class II | Active |
| Mectron | starlight pro - SHINY YELLOW -USA | FDA UDI | Class II | Active |
| Mectron | MULTIPIEZO PRO -perio -US- | FDA UDI | Class II | Active |
| Mectron | MT-Bone | FDA UDI | Class II | Active |
| Mectron | PL0719 -US- | FDA UDI | Class II | Active |
| Mectron | W1 -US- | FDA UDI | Class II | Active |
| Mectron | PIEZOSURGERY FLEX | FDA UDI | Class I | Active |
| Mectron | PD0328B | FDA UDI | Class II | Active |
| Mectron | R1 + K10 | FDA UDI | Class II | Active |
| Mectron | PIEZOSURGERY ® TOUCH -essential -US- | FDA UDI | Class II | Active |
| Mectron | OP9 -US | FDA UDI | Class II | Active |
| Mectron | D05120 + K10 -US | FDA UDI | Class II | Active |
| Mectron | TIP TF16D90 -US- | FDA UDI | Class II | Active |
| Mectron | EN3 -US | FDA UDI | Class II | Active |
| Mectron | INSERT ICS -US | FDA UDI | Class II | Active |
| Mectron | W4 | FDA UDI | Class II | Active |
| Mectron | R5 + K10 | FDA UDI | Class II | Active |
| Mectron | SLE2 | FDA UDI | Class II | Active |
| Mectron | P2 + K10 | FDA UDI | Class II | Active |
| Mectron | OT8R | FDA UDI | Class II | Active |
| Mectron | MULTIPIEZO PRO -basic -US- | FDA UDI | Class II | Active |
| Mectron | PD0118A | FDA UDI | Class II | Active |
| Mectron | R4 | FDA UDI | Class II | Active |
| Mectron | MT1-10 | FDA UDI | Class I | Active |
| Mectron | S4 | FDA UDI | Class II | Active |
| Mectron | CROWN PREP TIP TA12D90 -US | FDA UDI | Class II | Active |
| Mectron | OT1A -US | FDA UDI | Class II | Active |
| Mectron | MANIPOLO PIEZOSURGERY MEDICAL+ | FDA UDI | Class II | Active |
| Mectron | OP7 | FDA UDI | Class II | Active |
| Mectron | R2 | FDA UDI | Class II | Active |
| Mectron | MDI 2.5 -US | FDA UDI | Class II | Active |
| Mectron | RD4 + K10 | FDA UDI | Class II | Active |
| Mectron | PP10 | FDA UDI | Class II | Active |
| Mectron | CROWN PREP TIP TA14D60 -US | FDA UDI | Class II | Active |
| Mectron | PS TOUCH COMPLETE HANDPIECE | FDA UDI | Class II | Active |
| Mectron | E2 | FDA UDI | Class II | Active |
| Mectron | PP11 | FDA UDI | Class II | Active |
| Mectron | PD0223B | FDA UDI | Class II | Active |
| Mectron | OP6 -US | FDA UDI | Class II | Active |
| Mectron | MT9-13 | FDA UDI | Class I | Active |
| Mectron | EL1 | FDA UDI | Class II | Active |
| Mectron | COMPACT PIEZO LED -A- DBI | FDA UDI | Class II | Active |
| Mectron | R3 | FDA UDI | Class II | Active |
| Mectron | S8 + K10 | FDA UDI | Class II | Active |
| Mectron | D4 | FDA UDI | Class II | Active |
| Mectron | CROWN PREP TIP TA16D90 -US | FDA UDI | Class II | Active |
| Mectron | OP1 | FDA UDI | Class II | Active |
| Mectron | IM2P-15 | FDA UDI | Class II | Active |
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