Laser, Dental, Soft Tissue

What Is This Device?

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

How Is NVK Classified?

Laser, Dental, Soft Tissue is FDA product code NVK, Class 2, 21 CFR 878.4810.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 7 clearances under this code; the FDA took a median of 232 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Radiation Control for Health and Safety Act (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.