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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 the device name listed in this FDA 510(k) record. The listed applicant is Medency S.R.L.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) 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. The listed applicant is Medency S.R.L.. The 510(k) number is K232222.

When did Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) receive FDA 510(k) clearance?

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

Who is the listed applicant for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)?

The FDA 510(k) record lists Medency S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07529444Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental ImplantsRECRUITING

Other records listing Medency S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: NVK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)Shenzhen Soga Technology Co., Ltd.K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLCK250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.K230047Medical Diode Laser SystemsGigaalaser Company , Ltd.K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.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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