Name: Predicase
Price: 199 USD

K-number	K232222
Device name	Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
Applicant	Medency S.R.L.
Product code	NVK
Device class	Class II
Decision date	Nov 27, 2023
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.