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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 7 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | TIP AS6D | FDA UDI | Class II | Active |
| Acteon | MINILED AF2 OEM ADEC 500 G3 V3 | FDA UDI | Class II | Active |
| Acteon | BOX 4 TIPS PH2R | FDA UDI | Class II | Active |
| Acteon | CE1 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP PM2 | FDA UDI | Class II | Active |
| Acteon | MINILED DENTALEZ OEM KIT | FDA UDI | Class II | Active |
| Acteon | TIP SL3 II | FDA UDI | Class II | Active |
| Acteon | CS2 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP ET40D | FDA UDI | Class II | Active |
| Acteon | AIR N GO EASY SIRONA x 2BUSES | FDA UDI | Class I | Active |
| Acteon | TIP PMV3 | FDA UDI | Class II | Active |
| Acteon | 05.001.400 | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON LED US LIGHT GREY | FDA UDI | Class II | Active |
| Acteon | TIP PMV1 | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K10 LG 21 | FDA UDI | Class II | Active |
| Acteon | NEWTRON MODULE 4K3.7V PLUG US | FDA UDI | Class II | Active |
| Acteon | 03.000.412S | FDA UDI | Class II | Active |
| Acteon | TIP CS1 | FDA UDI | Class II | Active |
| Acteon | TIP CE2 II | FDA UDI | Class II | Active |
| Acteon | TIP RHS2F M+ STERILE | FDA UDI | Class II | Active |
| Acteon | TIP BS2R M+ STERILE | FDA UDI | Class II | Active |
| Acteon | TIP H3 MORITA | FDA UDI | Class II | Active |
| Acteon | MF KIT NEWTRON ADEC 61" AG V3 | FDA UDI | Class II | Active |
| Acteon | PACK PIEZOTOME 2 | FDA UDI | Class II | Active |
| Acteon | KIT DETARTRAGE GII SS PAM | FDA UDI | Class II | Active |
| Acteon | NEWTRON P5 XS B.LED KIT INTRO V4 | FDA UDI | Class II | Active |
| Acteon | NEWTRON P5 XS BLED NO TIP CBVS | FDA UDI | Class II | Active |
| Acteon | TIP IP3R | FDA UDI | Class II | Active |
| Acteon | CE3 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | PIEZOTOME SOLO LED US WO KIT | FDA UDI | Class II | Active |
| Acteon | TIP SL2 | FDA UDI | Class II | Active |
| Acteon | SL3 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP CAP3 | FDA UDI | Class II | Active |
| Acteon | TIP BS2R | FDA UDI | Class II | Active |
| Acteon | PACK NEWTRON II PARO LED | FDA UDI | Class II | Active |
| Acteon | 03.000.410S | FDA UDI | Class II | Active |
| Acteon | TIP CE1 II | FDA UDI | Class II | Active |
| Acteon | TIP 2 | FDA UDI | Class II | Active |
| Acteon | KIT ENDO SUCCES API SURGERY | FDA UDI | Class II | Active |
| Acteon | RHS5 M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | BS6 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP CS6 | FDA UDI | Class II | Active |
| Acteon | RHL6 M+ | FDA UDI | Class II | Active |
| Acteon | BS2L XL M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | MINILED OEM CD P107 OPT OPA7.5 | FDA UDI | Class II | Active |
| Acteon | PACK BS PZT 2 | FDA UDI | Class II | Active |
| Acteon | KIT SL SINUS LIFT | FDA UDI | Class II | Active |
| Acteon | Universal sterile irrigation line | FDA UDI | Class I | Active |
| Acteon | PAM GRISE MINILED NUE STD | FDA UDI | Class II | Active |
| Acteon | TIP CS3 | FDA UDI | Class II | Active |
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