Cleared Traditional

K201387 - Ultrafast, Ultrafast Plus, Ultrafast Lite
(FDA 510(k) Clearance)

K201387 · Dentlight, Inc. · Dental

Feb 2021

Decision

275d

Days

Class 2

Risk

K201387 is an FDA 510(k) clearance for the Ultrafast, Ultrafast Plus, Ultrafast Lite, a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Dentlight, Inc. (Plano, US). The FDA issued a Cleared decision on February 26, 2021, 275 days after receiving the submission on May 27, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K201387 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2020
Decision Date	February 26, 2021
Days to Decision	275 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — 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.