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510(k) K221322

CUSTMBITE Snoring System by Dental Choice Holdings, LLC — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2022
Date Received
May 6, 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

Other clearances by Dental Choice Holdings, LLC

  • K183315 — CustMBite Dental Guard (August 23, 2019)

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  • K253355 — Difiney Advanced Anti Snoring Device 4.0 (October 29, 2025)
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  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)