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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 4 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | TIP ET25S | FDA UDI | Class II | Active |
| Acteon | RHS2Fb M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | KIT LC EXTRACTION | FDA UDI | Class II | Active |
| Acteon | RHS4L M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | NEWTRON BOOSTER VET | FDA UDI | Class II | Active |
| Acteon | TIP SO4 | FDA UDI | Class II | Active |
| Acteon | PAM MINILED SP NUE | FDA UDI | Class II | Active |
| Acteon | P5 NEWTRON 115V | FDA UDI | Class II | Active |
| Acteon | PAM MINILED OEM BOUT GRISE | FDA UDI | Class II | Active |
| Acteon | NEWTRON P5 XS BLED NO TIP CBVS | FDA UDI | Class II | Active |
| Acteon | 03.000.407S | FDA UDI | Class II | Active |
| Acteon | SL1 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | RHL5 M+ | FDA UDI | Class II | Active |
| Acteon | TIP NINJA | FDA UDI | Class II | Active |
| Acteon | RHS6 M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | TIP CAP1 | FDA UDI | Class II | Active |
| Acteon | TIP 10Z MORITA | FDA UDI | Class II | Active |
| Acteon | TIP C20 | FDA UDI | Class II | Active |
| Acteon | PAM ML OEM SUPERCHARGED EMB | FDA UDI | Class II | Active |
| Acteon | 03.000.401S | FDA UDI | Class II | Active |
| Acteon | KIT PARO GII SS PAM | FDA UDI | Class II | Active |
| Acteon | BS2R XL M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP AS3D | FDA UDI | Class II | Active |
| Acteon | PAM MINILED BLACK ASS FINAL | FDA UDI | Class II | Active |
| Acteon | CS3 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP BS2R II | FDA UDI | Class II | Active |
| Acteon | TIP P2R | FDA UDI | Class II | Active |
| Acteon | PIEZOTOME CUBE EMB CANADA | FDA UDI | Class II | Active |
| Acteon | TIP BS1L M+ STERILE | FDA UDI | Class II | Active |
| Acteon | TIP SL2 II | FDA UDI | Class II | Active |
| Acteon | 03.000.408S | FDA UDI | Class II | Active |
| Acteon | TIP PFR | FDA UDI | Class II | Active |
| Acteon | TIP LC2 II | FDA UDI | Class II | Active |
| Acteon | MODULE SP NEWTRON 4K5V CTRL | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON LED LS PMAX XS CTRL | FDA UDI | Class II | Active |
| Acteon | TIP P15RD | FDA UDI | Class II | Active |
| Acteon | TIP BS2L M+ STERILE | FDA UDI | Class II | Active |
| Acteon | KIT PMS | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON 4K3,7V US CTRL | FDA UDI | Class II | Active |
| Acteon | TIP PMS3 | FDA UDI | Class II | Active |
| Acteon | MF KIT NEWTRON ADEC 81" AG V3 | FDA UDI | Class II | Active |
| Acteon | MINILED AOC BLUE RAY 3 | FDA UDI | Class II | Active |
| Acteon | RHL4L M+ | FDA UDI | Class II | Active |
| Acteon | TIP LC2L II | FDA UDI | Class II | Active |
| Acteon | MINILED DENTALEZ OEM KIT | FDA UDI | Class II | Active |
| Acteon | TIP 1S MORITA | FDA UDI | Class II | Active |
| Acteon | TIP ET18D MORITA | FDA UDI | Class II | Active |
| Acteon | PIEZOTOME 2 GP | FDA UDI | Class II | Active |
| Acteon | TIP H4L | FDA UDI | Class II | Active |
| Acteon | DB 1 M+ TIP N STER | FDA UDI | Class II | Active |
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