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510(k) K201387

Ultrafast, Ultrafast Plus, Ultrafast Lite by Dentlight, Inc. — Product Code NVK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2021
Date Received
May 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Dental, Soft Tissue
Device Class
Class II
Regulation Number
878.4810
Review Panel
DE
Submission Type

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

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