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510(k) K203606

Device
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
Applicant
Meris Investment Group
510(k) number
K203606
Product code
LRK  
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-10
Date received
2020-12-10
Regulation
872.5570
Classification name
Device, Anti-snoring
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gary Maas
Address
16688 7th St. S. Lakeland MN US 55043 55043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.2026-05-14
K252942ShaeferHShaeferh, LLC2026-04-10
K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.2026-03-03
K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.2026-03-02
K252976Park Dental Nylon MADPark Dental Research Corp.2025-12-18
K253868QuietLab ProQuietLab, LLC2025-12-05
K252161Hushd AveraGood Sleep CO Pte , Ltd.2025-11-25
K252525AIO BreatheAiomega, LLC2025-11-06
K252698NightGuard Aire MaxNightguard Express, LLC2025-11-03
K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLC2025-10-29
K251784Hushd Pro Z-LinkGood Sleep CO Pte , Ltd.2025-10-24
K251628Mandibular Advancement Device L07Dcstar, Inc.2025-10-22
K250028Anti Snore MouthpieceDongguan Yiyao Science & Technology Development Co., Ltd.2025-10-03
K243752Double Tube Herbst ApplianceThe Tmj Clinic PC2025-09-17
K252374Nylon flexTAP(R)Airway Technologies D/B/A Airway Management2025-09-11

Legacy Summary#

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FDA Review#

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