510(k) K241311

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) by Bernhard Förster GmbH — Product Code MQC

K241311 is an FDA 510(k) premarket notification submitted by Bernhard Förster GmbH for the device "Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.