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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 3 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | 03.000.406S | FDA UDI | Class II | Active |
| Acteon | TIP BS6 II | FDA UDI | Class II | Active |
| Acteon | MINILED BLACK | FDA UDI | Class II | Active |
| Acteon | NEWTRON P5 BLED KIT V4 | FDA UDI | Class II | Active |
| Acteon | RHS3L M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON 4K3.7V US | FDA UDI | Class II | Active |
| Acteon | TIP CS2 | FDA UDI | Class II | Active |
| Acteon | TIP IP3L | FDA UDI | Class II | Active |
| Acteon | TIP IP2L | FDA UDI | Class II | Active |
| Acteon | BS1 XXL M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | 03.000.403S | FDA UDI | Class II | Active |
| Acteon | 03.000.418S | FDA UDI | Class II | Active |
| Acteon | MINILED OEM MIDMARK | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON LED MIDMARK | FDA UDI | Class II | Active |
| Acteon | MINILED III SUPERCHARGED | FDA UDI | Class II | Active |
| Acteon | TIP TKW3 II | FDA UDI | Class II | Active |
| Acteon | 03.000.409S | FDA UDI | Class II | Active |
| Acteon | TIP IP1 | FDA UDI | Class II | Active |
| Acteon | TKW3 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | NEWTRON P5 XS BLEB 300ml | FDA UDI | Class II | Active |
| Acteon | NEWTRON MODULE 4K3.7V ADEC | FDA UDI | Class II | Active |
| Acteon | LC2 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP PFL | FDA UDI | Class II | Active |
| Acteon | BOX 4 TIPS PH2L | FDA UDI | Class II | Active |
| Acteon | NEWT BOOSTER US HP NEWT NO TIP | FDA UDI | Class II | Active |
| Acteon | KIT SINUS LIFT PZT 2 | FDA UDI | Class II | Active |
| Acteon | TIP SL5 II | FDA UDI | Class II | Active |
| Acteon | PAM ST GII R9002 & CG9C OEM | FDA UDI | Class II | Active |
| Acteon | IMPLANT CENTER | FDA UDI | Class II | Active |
| Acteon | TIP ET20 MORITA | FDA UDI | Class II | Active |
| Acteon | TIP ET25 | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K15 LG 21 | FDA UDI | Class II | Active |
| Acteon | PAM MINILED-N OEM SUPERCHARGED | FDA UDI | Class II | Active |
| Acteon | 03.000.404S | FDA UDI | Class II | Active |
| Acteon | AIR N GO EASY MIDWEST x 2BUSES | FDA UDI | Class I | Active |
| Acteon | TIP BS1RD II | FDA UDI | Class II | Active |
| Acteon | MINILED AF US | FDA UDI | Class II | Active |
| Acteon | BS4 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP ET40D MORITA | FDA UDI | Class II | Active |
| Acteon | TIP IP2R | FDA UDI | Class II | Active |
| Acteon | TIP 1 MORITA | FDA UDI | Class II | Active |
| Acteon | TIP RHS2H M+ STERILE | FDA UDI | Class II | Active |
| Acteon | LC1 XL M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K10 LG 25 | FDA UDI | Class II | Active |
| Acteon | KIT PERIOSOFT GII SS PAM | FDA UDI | Class II | Active |
| Acteon | TIP ET25 MORITA | FDA UDI | Class II | Active |
| Acteon | TIP P14D | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES IRR K25 LG 25 | FDA UDI | Class II | Active |
| Acteon | TIP EX2 | FDA UDI | Class II | Active |
| Acteon | TIP CE1 | FDA UDI | Class II | Active |
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