Cleared Traditional

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

K232222 · Medency S.R.L. · Dental

Nov 2023

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K232222 is an FDA 510(k) clearance for the Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo), a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Medency S.R.L. (Vicenza, IT). The FDA issued a Cleared decision on November 27, 2023, 124 days after receiving the submission on July 26, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K232222 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2023
Decision Date	November 27, 2023
Days to Decision	124 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.