Ultrafast, Ultrafast Plus, Ultrafast Lite

FDA 510(k) K201387 · Dentlight, Inc.

Substantially Equivalent

510(k) numberK201387

Submission

Device name
Ultrafast, Ultrafast Plus, Ultrafast Lite
Applicant
Dentlight, Inc.
Plano, TX, US
Received
May 27, 2020
Decision date
February 26, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NVK – Laser, Dental, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Specialty
General, Plastic Surgery

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

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Questions and answers

When was Ultrafast, Ultrafast Plus, Ultrafast Lite cleared by the FDA?

Ultrafast, Ultrafast Plus, Ultrafast Lite (K201387) received a 510(k) decision of Substantially Equivalent on February 26, 2021, 275 days after the submission was received.

What is the product code of K201387?

The FDA product code is NVK – Laser, Dental, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4810.