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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 6 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | TIP 5AE | FDA UDI | Class II | Active |
| Acteon | 03.000.424S | FDA UDI | Class II | Active |
| Acteon | 03.000.400.01S | FDA UDI | Class II | Active |
| Acteon | HANDPIECE SCANWAVE OEM PEN | FDA UDI | Class II | Active |
| Acteon | TIP PMV2 | FDA UDI | Class II | Active |
| Acteon | MF KIT NEWT.LED ADEC 61" MG V3 | FDA UDI | Class II | Active |
| Acteon | TIP PM3 | FDA UDI | Class II | Active |
| Acteon | RHS BASIC M+ N STER KIT | FDA UDI | Class II | Active |
| Acteon | TIP TK1-1S MORITA | FDA UDI | Class II | Active |
| Acteon | CE2 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | HANDPIECE MINILED AOC BLUE RAY 3 | FDA UDI | Class II | Active |
| Acteon | PAM MINILED AO BLUE RAY 3 | FDA UDI | Class II | Active |
| Acteon | BS1 RD M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP 1 | FDA UDI | Class II | Active |
| Acteon | MF KIT NEWT. LED ADEC 61"AG V3 | FDA UDI | Class II | Active |
| Acteon | TIP SL3 M+ STERILE | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON LED 4K5V DENTALEZ | FDA UDI | Class II | Active |
| Acteon | AIR N GO + ADAPTATEUR KAVO USA | FDA UDI | Class I | Active |
| Acteon | PAM LUMIERE A LEDS V3 SATELEC | FDA UDI | Class II | Active |
| Acteon | P5 XS 115V EMB FINAL | FDA UDI | Class II | Active |
| Acteon | TIP BS1L II | FDA UDI | Class II | Active |
| Acteon | TIP BS1 RD M+ STERILE | FDA UDI | Class II | Active |
| Acteon | TIP BS5 II | FDA UDI | Class II | Active |
| Acteon | TIP ET40 MORITA | FDA UDI | Class II | Active |
| Acteon | TIP BS1 | FDA UDI | Class II | Active |
| Acteon | HANDPIECE PIEZOTOME 2 LED | FDA UDI | Class II | Active |
| Acteon | SCANWAVE OEM PEN GRAY3 | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES IRR K20 LG 21 | FDA UDI | Class II | Active |
| Acteon | KIT LC EXTRACTION PTZ 2 | FDA UDI | Class II | Active |
| Acteon | NEWT BOOSTER HPNEWT CBVS KITV4 | FDA UDI | Class II | Active |
| Acteon | TIP 10P | FDA UDI | Class II | Active |
| Acteon | TKW1 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP CS5 | FDA UDI | Class II | Active |
| Acteon | NEWT P5 B LED USA KIT INTRO V4 | FDA UDI | Class II | Active |
| Acteon | MODULE SP NEWTRON 4K5V II CTRL | FDA UDI | Class II | Active |
| Acteon | PAM MINILED-N ORTHO2 ASS.FINAL | FDA UDI | Class II | Active |
| Acteon | TIP CE3 II | FDA UDI | Class II | Active |
| Acteon | KITS INSERT BS SL TKW | FDA UDI | Class II | Active |
| Acteon | PACK NEWTRON 2 LED NO TIPS | FDA UDI | Class II | Active |
| Acteon | TIP LC1 | FDA UDI | Class II | Active |
| Acteon | TIP TKW4 II | FDA UDI | Class II | Active |
| Acteon | TIP ET25L | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K25 LG 21 | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON 4K5V DENTALEZ | FDA UDI | Class II | Active |
| Acteon | KIT CREST SPLITTING PZTII LED | FDA UDI | Class II | Active |
| Acteon | KIT IMPLANTPROTECT | FDA UDI | Class II | Active |
| Acteon | CS5 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | MF KIT NEWTRON ADEC 61" MG V3 | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON USA CORDON F00184 | FDA UDI | Class II | Active |
| Acteon | CS1 M+ TIP N STER | FDA UDI | Class II | Active |
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