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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 8 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | TIP SL4 II | FDA UDI | Class II | Active |
| Acteon | SL INTRALIFT KIT | FDA UDI | Class II | Active |
| Acteon | 03.000.425S | FDA UDI | Class II | Active |
| Acteon | PAM MINILED-N AF OEM ASS. FIN | FDA UDI | Class II | Active |
| Acteon | PMAX XS 115V | FDA UDI | Class II | Active |
| Acteon | PRO-ULTRA NEWTRON 115V | FDA UDI | Class II | Active |
| Acteon | TIP PFL MORITA | FDA UDI | Class II | Active |
| Acteon | Universal sterile irrigation line | FDA UDI | Class I | Active |
| Acteon | NEWT BOOSTER CBVS HPNEWT NOTIP | FDA UDI | Class II | Active |
| Acteon | TIP BS4 M+ STERILE | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K30 LG25 MORITA | FDA UDI | Class II | Active |
| Acteon | IMPLANT CENTER 2 LED GP | FDA UDI | Class II | Active |
| Acteon | TIP PMV5 | FDA UDI | Class II | Active |
| Acteon | 03.000.400.05S | FDA UDI | Class II | Active |
| Acteon | DUAL HANDPIECE ULTRASONIC KIT | FDA UDI | Class II | Active |
| Acteon | TIP SL1 II | FDA UDI | Class II | Active |
| Acteon | PIEZOTOME 2 CORD US | FDA UDI | Class II | Active |
| Acteon | 05.001.401 | FDA UDI | Class II | Active |
| Acteon | TIP P15LD | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES IRR K20 LG 25 | FDA UDI | Class II | Active |
| Acteon | TIP 10X | FDA UDI | Class II | Active |
| Acteon | MOD OEM MINILED NU 24V +/-20% | FDA UDI | Class II | Active |
| Acteon | TIP H2L | FDA UDI | Class II | Active |
| Acteon | TIP BS1 XXL M+ STERILE | FDA UDI | Class II | Active |
| Acteon | TIP ET18D | FDA UDI | Class II | Active |
| Acteon | TIP TK1-1L | FDA UDI | Class II | Active |
| Acteon | TIP RHS3R M+ STERILE | FDA UDI | Class II | Active |
| Acteon | P5 NEWTRON CSA | FDA UDI | Class II | Active |
| Acteon | RHS EXPERT M+ N STER KIT | FDA UDI | Class II | Active |
| Acteon | ULTRAWAVE XS LED HAND PIECE | FDA UDI | Class II | Active |
| Acteon | KIT TIPS CE PZT 2 | FDA UDI | Class II | Active |
| Acteon | TIP ASLD | FDA UDI | Class II | Active |
| Acteon | TIP SL1 M+ STERILE | FDA UDI | Class II | Active |
| Acteon | RHS4R M+ N STER TIP | FDA UDI | Class II | Active |
| Acteon | PIEZOTOME SOLO LED - US | FDA UDI | Class II | Active |
| Acteon | TIP H2R | FDA UDI | Class II | Active |
| Acteon | KIT INSERT CAP | FDA UDI | Class II | Active |
| Acteon | TIP TKW1 | FDA UDI | Class II | Active |
| Acteon | HANDPIECE MINILED AF2 OEM | FDA UDI | Class II | Active |
| Acteon | TIP NINJA II | FDA UDI | Class II | Active |
| Acteon | TIP 3 | FDA UDI | Class II | Active |
| Satelec | PIEZOTOME SOLO M+ US | FDA UDI | Class II | Active |
| Acteon | TIP TKW2 II | FDA UDI | Class II | Active |
| Acteon | KIT ENDO SUCCESS RETREATEMENT | FDA UDI | Class II | Active |
| Acteon | TIP BS4 | FDA UDI | Class II | Active |
| Acteon | TIP PM4 | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES IRR K25 LG 21 | FDA UDI | Class II | Active |
| Acteon | SL5 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | SL INTRALIFT KIT PZT2 | FDA UDI | Class II | Active |
| Acteon | PAM STER NG R9002 SATELEC | FDA UDI | Class II | Active |
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