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Satelec

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Satelec is a medical device manufacturer, with 463 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II, Class I and Unclassified) as of 12 Nov 2026.

Devices
463

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 439
  • FDA 510(k) 24
  • EUDAMED 5

A device listed in two registries counts in both.

Device classes
  • FDA Class II 445
  • FDA Class I 15
  • FDA Unclassified 3
Identifiers
  • DUNS 381582196

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.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue463

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Company details

DUNS number
381582196
Phone
+33556340607

Frequently asked questions

How many devices does Satelec have in the registry?

The registry currently lists 463 devices for Satelec. Devices recorded under merged duplicate company entries are counted once.

Which registries list Satelec's devices?

Among its 50 most recently registered devices, Satelec has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Satelec's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Satelec's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Satelec in the registry?

The most recently registered devices listed for Satelec include ACTEON PZ1 II, ACTEON PZ3 II, BUSE PERIO MAINT AIR N GO EASY F10128 and SP NEWTRON LED 4K3.7V US EMB F55542.

Generated automatically from registry data and not verified by a human reviewer.