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510(k) K243752

Double Tube Herbst Appliance by The Tmj Clinic PC — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2025
Date Received
December 5, 2024
Clearance Type
Abbreviated
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 The Tmj Clinic PC

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  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)