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FDA 510(k)

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece

K-Number: K222845 · 2023-11-28

Decision Date2023-11-28
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is a medical device manufactured by Frey Oral Technologies, LLC. It received FDA 510(k) clearance on 2023-11-28 under approval number K222845. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is a medical device that received FDA 510(k) clearance on 2023-11-28. It is manufactured by Frey Oral Technologies, LLC. The 510(k) number is K222845.

When was Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece approved by the FDA?

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece received FDA 510(k) clearance on 2023-11-28, under approval number K222845.

What company makes Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is manufactured by Frey Oral Technologies, LLC.

What is the FDA product code for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

The FDA product code for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is MQC.

Related Clinical Trials

Related Devices (Code: MQC)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.