Cleared Traditional

K232222 - Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232222 · Medency S.R.L. · Dental device
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Nov 2023
Decision
124d
Days
Class 2
Risk

K232222 is an FDA 510(k) clearance for the Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo T.... Classified as Laser, Dental, Soft Tissue (product code NVK), Class II - Special Controls.

Submitted by Medency S.R.L. (Vicenza, IT). The FDA issued a Cleared decision on November 27, 2023 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4810 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Medency S.R.L. devices

Submission Details

510(k) Number K232222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 127d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NVK Laser, Dental, Soft Tissue
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NVK Laser, Dental, Soft Tissue

All 15
Devices cleared under the same product code (NVK) and FDA review panel - the closest regulatory comparables to K232222.
Gemini NOVA 810+980 Soft Tissue Laser
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K243764 · Wuhan Pioon Technology Co., Ltd. · May 2025
Medical Diode Laser Systems
K230047 · Gigaalaser Company , Ltd. · Mar 2024
Dawn Diode Laser System
K232885 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Feb 2024
Solea
K221761 · Convergent Dental, Inc. · Sep 2022