Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dental Choice Holdings, LLC. It received FDA 510(k) clearance on 2022-10-27 under 510(k) 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. The listed applicant is Dental Choice Holdings, LLC. The 510(k) number is K221322.

When did CUSTMBITE Snoring System receive FDA 510(k) clearance?

CUSTMBITE Snoring System received FDA 510(k) clearance on 2022-10-27, under 510(k) number K221322.

Who is the listed applicant for CUSTMBITE Snoring System?

The FDA 510(k) record lists Dental Choice Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTMBITE Snoring System?

The FDA product code for CUSTMBITE Snoring System is LRK.

Other records listing Dental Choice Holdings, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183315CustMBite Dental Guard

Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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.

↑