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510(k) K192581

Device
The NightBlocks Appliance
Applicant
Advanced Facialdontics LLC
510(k) number
K192581
Product code
LQZ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-28
Date received
2019-09-19
Regulation
872.5570
Classification name
Device, Jaw Repositioning
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Scott Simonetti
Address
325 Lake Ave. Unit 759 St James NY US 11780 11780

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LQZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233754AIO BreatheAiomega, LLC2024-02-23
K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC2023-07-12
K203712The SlideBiotex, Inc.2021-07-20
K191320Slow Wave DS8Slow Wave, Inc.2020-10-02
K162816SML-OSA2 AppliancesSelane Products, Inc.2017-07-27
K130130ATG/SM-OSA APPLIANCESSelane Products, Inc.2013-08-26
K112627MILLENIUM ANTI-SNORING DEVICEMillenium Dental Laboratory, Inc.2012-06-06
K112766SNORKELFellmar Company2012-06-04
K113201NARVAL CCResmed Sas2011-12-01
K090911IST SNORING APPLIANCEDental Crafters2009-09-11
K091035FULL BREATH SLEEP APPLIANCE LOWER (FBSL)Bryan Keropian Dds2009-06-24
K061228FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSORBryan Keropian Dds2006-05-26
K053065FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)Bryan Keropian Dds2006-01-03
K052862FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)Bryan Keropian Dds2005-12-30
K032410SNORENTIJames P Boyd2005-02-28

Legacy Summary#

summary

FDA Review#

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