Premium One Implant Systems

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172560

Identifiers

510(k) Number: K172560 FDA 510(k)
FDA Product Code: DZE FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.3640 FDA 510(k)
Regulation Number: 872.3640 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Premium One Implant Systems is a dental implant device designed for osseointegrated fixation in the jawbone. It is classified under dental implant systems and is intended for use in reconstructive oral and maxillofacial procedures, providing stable support for prosthetic teeth or restorations.

These systems are supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under Traditional review (K172560) and MDD compliance. The device is manufactured by Sweden & Martina S.P.A. and distributed from Due Carrare, Italy. No MRI safety information or reusable specifications are provided in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K172560	Class II	Active

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Manufacturer

Manufacturer: Sweden & Martina S.p.a.

Sources (2)

FDA 510(k) K172560 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026