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FDA 510(k)

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

K-Number: K232222 · 2023-11-27

ApplicantMedency S.R.L.
Decision Date2023-11-27
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) is a medical device manufactured by Medency S.R.L.. It received FDA 510(k) clearance on 2023-11-27 under approval number K232222. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)?

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by Medency S.R.L.. The 510(k) number is K232222.

When was Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) approved by the FDA?

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) received FDA 510(k) clearance on 2023-11-27, under approval number K232222.

What company makes Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)?

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) is manufactured by Medency S.R.L..

What is the FDA product code for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)?

The FDA product code for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) is NVK.

Related Clinical Trials

NCT06960161 Exploring the Use of Phototherapy to Improve CPAP Compliance RECRUITING NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING

Other Devices by Medency S.R.L.

K240543Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

Related Devices (Code: NVK)

K213428EdgeProBiolase, Inc. K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC K203396DEKA SMARTPERIOEl.En Electronic Engineering Spa K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. K221761SoleaConvergent Dental, Inc. K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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