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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 9 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | NEWTRON LED MODULE 4K5V PLUG | FDA UDI | Class II | Active |
| Acteon | 03.000.423S | FDA UDI | Class II | Active |
| Acteon | HANDPIECE STER SP NEWTRON SATELEC | FDA UDI | Class II | Active |
| Acteon | HANDPIECE MINILED AOC BLUERAY 3 BLACK | FDA UDI | Class II | Active |
| Acteon | TIP EXR | FDA UDI | Class II | Active |
| Acteon | MINILED III SUPERCHARGED | FDA UDI | Class II | Active |
| Acteon | KIT PARO GII with Handpiece | FDA UDI | Class II | Active |
| Acteon | MINILED AOC BLUERAY 3 BLACK | FDA UDI | Class II | Active |
| Acteon | CS6 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | 03.000.405S | FDA UDI | Class II | Active |
| Acteon | P5 NEWTRON 115V | FDA UDI | Class II | Active |
| Acteon | SP NEWT 4K3,7V V3 ADEC CTRL | FDA UDI | Class II | Active |
| Acteon | TIP TKW5 II | FDA UDI | Class II | Active |
| Acteon | 03.000.402S | FDA UDI | Class II | Active |
| Acteon | HANDPIECE NEWTRON SLIM B.LED 54.0581.00 | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K30 LG21 MORITA | FDA UDI | Class II | Active |
| Acteon | TIP BS1S II | FDA UDI | Class II | Active |
| Acteon | TIP ET20D MORITA | FDA UDI | Class II | Active |
| Acteon | CMF KIT NON-STERIL | FDA UDI | Class II | Active |
| Acteon | NEWT BOOSTER HP NEWT. US KITV4 | FDA UDI | Class II | Active |
| Acteon | TIP TKW3 | FDA UDI | Class II | Active |
| Acteon | NEWT OEM KIT AG61 WITH HARNESS | FDA UDI | Class II | Active |
| Acteon | NEWTRON P5 XS B LED CBVS | FDA UDI | Class II | Active |
| Acteon | LC2R M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K10 LG21 MORITA | FDA UDI | Class II | Active |
| Acteon | TIP LC1 90° | FDA UDI | Class II | Active |
| Acteon | KIT BDR GII SS PAM | FDA UDI | Class II | Active |
| Acteon | TIP H4R | FDA UDI | Class II | Active |
| Acteon | NEWTRON BOOSTER USA NO TIP | FDA UDI | Class II | Active |
| Acteon | HANDPIECE CHIRURGICAL PIEZOTOME | FDA UDI | Class II | Active |
| Acteon | SCANWAVE OEM PEN ASS FINAL | FDA UDI | Class II | Active |
| Acteon | KIT INSERT BS PZT II | FDA UDI | Class II | Active |
| Acteon | P5 NEWTRON LED | FDA UDI | Class II | Active |
| Acteon | RHL4R M+ | FDA UDI | Class II | Active |
| Acteon | BOX 4 FILES K15 LG 25 | FDA UDI | Class II | Active |
| Suprasson P5 Booster | K961158 | FDA 510(k) | Class II | Active |
| Suni Max | K000049 | FDA 510(k) | Class I | Active |
| Lasersat Co2 | K904067 | FDA 510(k) | Class II | Active |
| Team-Up Tm Dental Electronic Anesthesia System | K011001 | FDA 510(k) | U | Active |
| Acta | K961735 | FDA 510(k) | Class II | Active |
| Implant Center 2 | K091252 | FDA 510(k) | Class II | Active |
| Is 40 Micromotor | K042787 | FDA 510(k) | Class I | Active |
| Sp Newtron Module | K033764 | FDA 510(k) | Class II | Active |
| Suprasson P Max | K942139 | FDA 510(k) | Class II | Active |
| Hemostasyl Paste | K082116 | FDA 510(k) | U | Active |
| Mini L.e.d. Oem Module | K040808 | FDA 510(k) | Class II | Active |
| Cocoon Hygienist | K040529 | FDA 510(k) | Class I | Active |
| Air-N-Go | K110379 | FDA 510(k) | Class I | Active |
| Piezoelectric System | K100410 | FDA 510(k) | Class II | Active |
| Mini L.e.d., Model: Mini L.e.d., Model Smartlite Mini | K032465 | FDA 510(k) | Class II | Active |
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