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Sign in to claim this brandSatelec
US
Last updated May 27, 2026
What Satelec makes
The company manufactures ultrasonic dental and surgical instruments, including handpiece tips and full systems for scaling, debridement, and periodontal treatment. Their portfolio also covers dental abrasive air jet systems and polymerization lamps for curing dental materials. These devices are designed for precision cleaning, tissue removal, and surgical applications in dental and oral healthcare settings.
The devices are classified under FDA’s Class I and Class II regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device regulations.
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 Satelec manufacture?
Satelec specializes in ultrasonic dental and surgical instruments. Their product range includes handpiece tips and full systems for ultrasonic scaling and debridement, particularly for periodontal treatment. They also produce dental abrasive air jet systems and polymerization lamps used for curing dental materials. These devices are designed for precision cleaning, tissue removal, and surgical applications in dental and oral healthcare.
Where is Satelec based, and what regulations do they follow?
Satelec is based in the United States. As a manufacturer, they develop and distribute devices in compliance with U.S. medical device regulations, including those governing classification, listing, and post-market requirements. Their devices are designed to meet the standards expected for use in dental and surgical settings within the country.
Which regulatory registries list Satelec’s devices?
Satelec’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Satelec’s devices classified under FDA regulations?
Satelec’s devices fall under FDA’s Class I and Class II regulatory categories. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate 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 benefits.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- acteongroup.com
- —
- —
- [email protected]
- Phone
- +33556340607
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 381582196
Catalogue (458)
Page 5 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | BOX 4 FILES K25 LG 25 | FDA UDI | Class II | Active |
| Acteon | TIP S12-7D MORITA | FDA UDI | Class II | Active |
| Acteon | BS5 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP ET20 | FDA UDI | Class II | Active |
| Acteon | KIT INTRO V4 | FDA UDI | Class II | Active |
| Acteon | 03.000.426S | FDA UDI | Class II | Active |
| Acteon | KIT PMV | FDA UDI | Class II | Active |
| Acteon | PRO-ULTRA NEWTRON HANDPIECE | FDA UDI | Class II | Active |
| Acteon | ULTRAWAVE XS LED | FDA UDI | Class II | Active |
| Acteon | PAM MINILED AF | FDA UDI | Class II | Active |
| Acteon | DB 2 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON 4K5V | FDA UDI | Class II | Active |
| Acteon | TIP LC2R | FDA UDI | Class II | Active |
| Acteon | PACK LC EXTRACTION PZT 2 LED | FDA UDI | Class II | Active |
| Acteon | TIP ET40 | FDA UDI | Class II | Active |
| Acteon | 03.000.421S | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON LED 4K3,7V US CTRL | FDA UDI | Class II | Active |
| Acteon | KIT EXCAVUS STD | FDA UDI | Class II | Active |
| Acteon | NINJA M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP PMS1 | FDA UDI | Class II | Active |
| Acteon | Sterile irrigation line + perfo | EUDAMEDFDA UDI | Class I | Active |
| Acteon | HANDPIECE NEWTRON SLIM 54.0580.00 | FDA UDI | Class II | Active |
| Acteon | PIEZOTOME PACK | FDA UDI | Class II | Active |
| Acteon | TIP PFR MORITA | FDA UDI | Class II | Active |
| Acteon | KIT NEWTRON PARO | FDA UDI | Class II | Active |
| Acteon | MODULE OEM MINILED EMBALLE | FDA UDI | Class II | Active |
| Acteon | MINILED A-DEC 500 OEM KIT V3 | FDA UDI | Class II | Active |
| Acteon | IMPLANT CENTER + PACK | FDA UDI | Class II | Active |
| Acteon | HANDPIECE P5 PRO VET | FDA UDI | Class II | Active |
| Acteon | MF KIT NEWT. LED ADEC 81"MG V3 | FDA UDI | Class II | Active |
| Acteon | TIP TK1-1S | FDA UDI | Class II | Active |
| Acteon | TIP TKW5 | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K10 LG25 MORITA | FDA UDI | Class II | Active |
| Acteon | NEWTR P5 B LED CBVS | FDA UDI | Class II | Active |
| Acteon | TIP EXL | FDA UDI | Class II | Active |
| Acteon | TIP PFU MORITA | FDA UDI | Class II | Active |
| Acteon | TIP RHS6 M+ STERILE | FDA UDI | Class II | Active |
| Acteon | KIT INTRO V3 | FDA UDI | Class II | Active |
| Acteon | BS6 XXL M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | BOX 4 TIPS PH1 | FDA UDI | Class II | Active |
| Acteon | KIT ADEC SLIM LED GREY 3 - 61" | FDA UDI | Class II | Active |
| Acteon | TIP SL2 M+ STERILE | FDA UDI | Class II | Active |
| Acteon | LC2L M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | RHS2Hb M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | MINILED DENTALEZ OEM KIT | FDA UDI | Class II | Active |
| Acteon | SP NEWT. USA CD F00184/1-2-10P | FDA UDI | Class II | Active |
| Acteon | TIP CAP2 | FDA UDI | Class II | Active |
| Acteon | TIP H3 | FDA UDI | Class II | Active |
| Acteon | SP NEWT LED 4K3,7V V3 ADEC CTL | FDA UDI | Class II | Active |
| Acteon | BS2R M+ TIP N STER | FDA UDI | Class II | Active |
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