510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K232222Substantially Equivalent

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

Medency SRL, Vicenza, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232222 is the FDA 510(k) clearance record for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo), a class II device, cleared for Medency S.R.L. on under FDA product code NVK (Laser, Dental, Soft Tissue). FDA's definition for product code NVK reads: "Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry". FDA records list 2 510(k) clearances for Medency S.R.L., from to . As of , FDA records show no recalls naming K232222.

Clearance record

Decision date
Received
(124 days to decision)
Product code
NVK Laser, Dental, Soft Tissue
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medency S.R.L. Via Degli Ontani, 48, Vicenza, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NVK

Trailing 12 months
2 clearances under product code NVK in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NVK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260