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510(k) K213428

EdgePro by Biolase, Inc. — Product Code NVK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2021
Date Received
October 21, 2021
Clearance Type
Special
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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