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FDA 510(k)

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

K-Number: K203606 · 2021-03-10

ApplicantMeris Investment Group
Decision Date2021-03-10
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is a medical device manufactured by Meris Investment Group. It received FDA 510(k) clearance on 2021-03-10 under approval number K203606. 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 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is a medical device that received FDA 510(k) clearance on 2021-03-10. It is manufactured by Meris Investment Group. The 510(k) number is K203606.

When was Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) approved by the FDA?

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) received FDA 510(k) clearance on 2021-03-10, under approval number K203606.

What company makes Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is manufactured by Meris Investment Group.

What is the FDA product code for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

The FDA product code for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is LRK.

Related Clinical Trials

NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07608406 Modified Versus Clear Twin Block for Skeletal Class II Malocclusion NOT_YET_RECRUITING NCT07103941 IOA Preventing Occlusal Changes With MAD Use RECRUITING NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED NCT07575035 EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS NOT_YET_RECRUITING NCT06970171 Acceptance of Mandibular Advancement Devices ENROLLING_BY_INVITATION

Other Devices by Meris Investment Group

K230495Serena Sleep Night Guard

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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.

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