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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 2 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | BS1L M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | NEWTR P5 B LED USA SS INSERTS | FDA UDI | Class II | Active |
| Acteon | TIP SL1 | FDA UDI | Class II | Active |
| Acteon | COCOON VET. SPRAY 115V | FDA UDI | Class I | Active |
| Acteon | HANDPIECE NEWTRON SLIM B.LED BC BT | FDA UDI | Class II | Active |
| Acteon | LC1 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | KIT SP 4055 NEWT B.LED MORITA | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K15 LG21 MORITA | FDA UDI | Class II | Active |
| Acteon | TIP 10Z | FDA UDI | Class II | Active |
| Acteon | AIR N GO EASY KAVO x 2BUSES | FDA UDI | Class I | Active |
| Acteon | TIP RHS5 M+ STERILE | FDA UDI | Class II | Active |
| Acteon | NEWTRON MODULE 4K5V PLUG | FDA UDI | Class II | Active |
| Acteon | PAM MINILED OEM BOUTONS GR NUE | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K30 LG 21 | FDA UDI | Class II | Active |
| Acteon | RHS1 M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | HANDPIECE NEWTRON SLIM | FDA UDI | Class II | Active |
| Acteon | TIP CE3 | FDA UDI | Class II | Active |
| Acteon | PMAX XS 115V tips | FDA UDI | Class II | Active |
| Acteon | TIP TK2-1R | FDA UDI | Class II | Active |
| Acteon | PAM MINILED AOC BLUERAY3 BLACK | FDA UDI | Class II | Active |
| Acteon | KIT PERIOSOFT GII with Handpiece | FDA UDI | Class II | Active |
| Acteon | TIP TKW2 | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K15 LG25 MORITA | FDA UDI | Class II | Active |
| Acteon | TKW2 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | SL2 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | KIT ESSENTIAL 6 TIPS | FDA UDI | Class II | Active |
| Acteon | PAM MINILED III SUPERCHARGED | FDA UDI | Class II | Active |
| Acteon | TIP EX3 | FDA UDI | Class II | Active |
| Acteon | ULTRAWAVE P5 SS ACCESSOIRE | FDA UDI | Class II | Active |
| Acteon | TIP ETBD MORITA | FDA UDI | Class II | Active |
| Acteon | MOTEUR I-SURGE+ | FDA UDI | Class II | Active |
| Acteon | TIP 1S | FDA UDI | Class II | Active |
| Acteon | TIP AS9D | FDA UDI | Class II | Active |
| Acteon | TIP BS2L | FDA UDI | Class II | Active |
| Acteon | RHS3R M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K30 LG 25 | FDA UDI | Class II | Active |
| Acteon | CS4 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | P5 NEWTRON LED US | FDA UDI | Class II | Active |
| Acteon | TIP LC2R II | FDA UDI | Class II | Active |
| Acteon | MOTEUR IC2 LED | FDA UDI | Class II | Active |
| Acteon | NEWTRON BOOSTER USA | FDA UDI | Class II | Active |
| Acteon | TIP SL3 | FDA UDI | Class II | Active |
| Acteon | TIP EX1 | FDA UDI | Class II | Active |
| Acteon | KIT OEM NEWTRON LED VET | FDA UDI | Class II | Active |
| Acteon | MF KIT NEWTRON ADEC 81" MG V3 | FDA UDI | Class II | Active |
| Acteon | TIP ASRD | FDA UDI | Class II | Active |
| Acteon | TIP BS5 | FDA UDI | Class II | Active |
| Acteon | TIP S12-70D | FDA UDI | Class II | Active |
| Acteon | TKW5 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP CE2 | FDA UDI | Class II | Active |
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