Cleared Traditional

K230495 - Serena Sleep Night Guard (FDA 510(k) Clearance)

K230495 · Meris Investment Group · Dental device

Oct 2023

Decision

232d

Days

Risk

K230495 is an FDA 510(k) clearance for the Serena Sleep Night Guard. This device is classified as a Mouthguard, Prescription.

Submitted by Meris Investment Group (Lakeland, US). The FDA issued a Cleared decision on October 13, 2023, 232 days after receiving the submission on February 23, 2023.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K230495 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 23, 2023
Decision Date	October 13, 2023
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF