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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 1 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | TIP ET20D | FDA UDI | Class II | Active |
| Acteon | TIP LC1 II | FDA UDI | Class II | Active |
| Acteon | ML OEM SUPERCHARGED CD LG | FDA UDI | Class II | Active |
| Acteon | 03.000.411S | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON ASI CD LG2.07 | FDA UDI | Class II | Active |
| Acteon | TIP PFU | FDA UDI | Class II | Active |
| Acteon | BS1S M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP LC2 | FDA UDI | Class II | Active |
| Acteon | TIP P15LD MORITA | FDA UDI | Class II | Active |
| Acteon | TIP SL5 | FDA UDI | Class II | Active |
| Acteon | TIP PM1 | FDA UDI | Class II | Active |
| Acteon | TIP PMS2 | FDA UDI | Class II | Active |
| Acteon | TIP LC1 90° II | FDA UDI | Class II | Active |
| Acteon | TIP ETBD | FDA UDI | Class II | Active |
| Acteon | TKW4 II TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP P2L | FDA UDI | Class II | Active |
| Acteon | KIT PERFECT'MARGIN ROUNDED | FDA UDI | Class II | Active |
| Acteon | ULTRAWAVE HAND PIECE | FDA UDI | Class II | Active |
| Acteon | ULTRAWAVE P5 | FDA UDI | Class II | Active |
| Acteon | P5 XS LED 115V NO TIPS | FDA UDI | Class II | Active |
| Acteon | TIP BS1 II | FDA UDI | Class II | Active |
| Acteon | TIP SL4 | FDA UDI | Class II | Active |
| Acteon | P5 XS LED 115V | FDA UDI | Class II | Active |
| Acteon | PIEZOTOME CUBE EMB USA | FDA UDI | Class II | Active |
| Acteon | TIP TKW1 II | FDA UDI | Class II | Active |
| Acteon | P5 XS 115V +n°1-10Z-H3 | FDA UDI | Class II | Active |
| Acteon | AIR N GO EASY WH x 2BUSES | FDA UDI | Class I | Active |
| Acteon | TIP SO4 MORITA | FDA UDI | Class II | Active |
| Acteon | NEWT BOOSTER HP NEWT. VET 115V | FDA UDI | Class II | Active |
| Acteon | TIP ETPR | FDA UDI | Class II | Active |
| Acteon | MINILED OEM A-DEC 500 G3 V3 | FDA UDI | Class II | Active |
| Acteon | TIP BS2L II | FDA UDI | Class II | Active |
| Acteon | TIP H1 | FDA UDI | Class II | Active |
| Acteon | TIP RHS3L M+ STERILE | FDA UDI | Class II | Active |
| Acteon | NEWT LED OEM KIT AG61 +HARNESS | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON LED CORD ADEC MG | FDA UDI | Class II | Active |
| Acteon | SL4 M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | TIP TK2-1L | FDA UDI | Class II | Active |
| Acteon | 03.000.419S | FDA UDI | Class II | Active |
| Acteon | TIP CS4 | FDA UDI | Class II | Active |
| Acteon | TIP BS4 II | FDA UDI | Class II | Active |
| Acteon | KIT INTRO with Handpiece | FDA UDI | Class II | Active |
| Acteon | TIP BS6 XXL M+ STERILE | FDA UDI | Class II | Active |
| Acteon | TIP TKW4 | FDA UDI | Class II | Active |
| Acteon | TIP LC2L | FDA UDI | Class II | Active |
| Acteon | KIT ADEC SLIM LED GREY 3 - 81" | FDA UDI | Class II | Active |
| Acteon | BS2L M+ TIP N STER | FDA UDI | Class II | Active |
| Acteon | SP NEWTRON LED OEM CTRL | FDA UDI | Class II | Active |
| Acteon | HANDPIECE NEWTRON SLIM B.LED BL BT | FDA UDI | Class II | Active |
| Acteon | TIP PMV6 | FDA UDI | Class II | Active |
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