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FDA 510(k)

Double Tube Herbst Appliance

K-Number: K243752 · 2025-09-17

ApplicantThe Tmj Clinic PC
Decision Date2025-09-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Double Tube Herbst Appliance is the device name listed in this FDA 510(k) record. The listed applicant is The Tmj Clinic PC. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K243752. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Double Tube Herbst Appliance?

Double Tube Herbst Appliance is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is The Tmj Clinic PC. The 510(k) number is K243752.

When did Double Tube Herbst Appliance receive FDA 510(k) clearance?

Double Tube Herbst Appliance received FDA 510(k) clearance on 2025-09-17, under 510(k) number K243752.

Who is the listed applicant for Double Tube Herbst Appliance?

The FDA 510(k) record lists The Tmj Clinic PC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Double Tube Herbst Appliance?

The FDA product code for Double Tube Herbst Appliance is LRK.

Other records listing The Tmj Clinic PC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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