510(k) K223624

Emerald Herbst by Island Dental Lab, Inc Dba Emerald Dental — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2023
Date Received
December 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type