Cleared Traditional

K232448 - FREEPRINT® splintmaster (FDA 510(k) Clearance)

K232448 · Detax GmbH · Dental device

Oct 2023

Decision

59d

Days

Risk

K232448 is an FDA 510(k) clearance for the FREEPRINT® splintmaster. This device is classified as a Mouthguard, Prescription.

Submitted by Detax GmbH (Ettingen, DE). The FDA issued a Cleared decision on October 12, 2023, 59 days after receiving the submission on August 14, 2023.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K232448 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 14, 2023
Decision Date	October 12, 2023
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF