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Spelna, Inc.

United StatesFDA applicant, unverified

Devices
11

What Spelna, Inc. makes

Spelna, Inc. manufactures dental and podiatric ultrasonic and rotary instruments, including piezocurretage devices (e.g., SATELEC SUPRASSON PIEZOMATIC P2 and SATALEC SEPTOSONIC SC 80/SC 120), ultrasonic scalers (e.g., SATELEC PROPHY UNIT PU 2000S), and rotary handpieces (e.g., SATALEC SERVOTORQUE S2 SX2). Their portfolio also includes podiatry-specific tools like the 5X2 SATALEC CHIROPODY CASE and dental polishing units (e.g., MEDILAC SR4 & SR 40).

These devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Satelec Suprasson Piezomatic P2 Ref K832664

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Satelec Prophy Unit Pu 2000S Ref K832674

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Satalec Septosonic Sc 80/Sc 120 Ref K852527

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Satelec Suprasson Sp 3055 Ref K832665

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Satelec Prophy Unit Pu-2000 Ref K832673

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Satalec Servotorque S2 SX2 Ref K852524

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Satalec Piezotec Ref K852525

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 5X2 Satalec Chiropody Case Ref K853200

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Satalec Servotome Ref K852522

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Medilac #SR4 & Sr 40 Ref K820256

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Satlec Prophy Unit Pu 3055 Ref K852521

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-11 of 11

Frequently asked questions

How many devices does Spelna, Inc. have in the registry?

The registry currently lists 11 devices for Spelna, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Spelna, Inc.'s devices?

Among its 11 most recently registered devices, Spelna, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Spelna, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Spelna, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Spelna, Inc. in the registry?

The most recently registered devices listed for Spelna, Inc. include SATELEC SUPRASSON PIEZOMATIC P2, SATELEC PROPHY UNIT PU 2000S, SATALEC SEPTOSONIC SC 80/SC 120 and SATELEC SUPRASSON SP 3055.

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