FDA.reportPublic FDA data

510(k) K223624

Device
Emerald Herbst
Applicant
Island Dental Lab, Inc Dba Emerald Dental
510(k) number
K223624
Product code
LRK
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-10
Date received
2022-12-05
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
Israel Wettenstein
Address
76 S. Central Ave. #1d Valley Stream NY US 11580 11580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRK#

510(k), Device, Applicant table
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K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.2026-05-14
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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
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