510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NVKClass II

Laser, Dental, Soft Tissue

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

NVK is the FDA product code for Laser, Dental, Soft Tissue, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry". As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NVK
Device name
Laser, Dental, Soft Tissue
FDA definition
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
2

Clearances, product code NVK

By decision year
17 clearances under product code NVK with a decision year between 2005 and 2026, 2022 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code NVK by decision year
YearClearances
20051
20214
20225
20231
20242
20252
20262

Applicants with the most clearances

Product code NVK
Applicants holding the most 510(k) clearances under product code NVK
ApplicantClearances
Shenzhen Soga Technology Co., Ltd.3
Azena Medical2
El.en. Electronic Engineering SpA2
Biolase, Inc.1
Convergent Dental1
Dentlight Inc.1
Gigaalaser Company Ltd.1
Guilin Woodpecker Medical Instrument Co., Ltd1
Kavo America1
Matelaser, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order