CUSTMBITE Snoring System
K-Number: K221322 · 2022-10-27
ApplicantDental Choice Holdings, LLC
Decision Date2022-10-27
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CUSTMBITE Snoring System is a medical device manufactured by Dental Choice Holdings, LLC. It received FDA 510(k) clearance on 2022-10-27 under approval number K221322. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CUSTMBITE Snoring System?
CUSTMBITE Snoring System is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Dental Choice Holdings, LLC. The 510(k) number is K221322.
When was CUSTMBITE Snoring System approved by the FDA?
CUSTMBITE Snoring System received FDA 510(k) clearance on 2022-10-27, under approval number K221322.
What company makes CUSTMBITE Snoring System?
CUSTMBITE Snoring System is manufactured by Dental Choice Holdings, LLC.
What is the FDA product code for CUSTMBITE Snoring System?
The FDA product code for CUSTMBITE Snoring System is LRK.
Other Devices by Dental Choice Holdings, LLC
Related Devices (Code: LRK)
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.