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FDA 510(k)

ACRYLIC HERBST APPLIANCE

K-Number: K113126 · 2013-07-17

ApplicantGergens Orthodontic Lab
Decision Date2013-07-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACRYLIC HERBST APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Gergens Orthodontic Lab. It received FDA 510(k) clearance on 2013-07-17 under 510(k) number K113126. 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 ACRYLIC HERBST APPLIANCE?

ACRYLIC HERBST APPLIANCE is a medical device that received FDA 510(k) clearance on 2013-07-17. The listed applicant is Gergens Orthodontic Lab. The 510(k) number is K113126.

When did ACRYLIC HERBST APPLIANCE receive FDA 510(k) clearance?

ACRYLIC HERBST APPLIANCE received FDA 510(k) clearance on 2013-07-17, under 510(k) number K113126.

Who is the listed applicant for ACRYLIC HERBST APPLIANCE?

The FDA 510(k) record lists Gergens Orthodontic Lab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACRYLIC HERBST APPLIANCE?

The FDA product code for ACRYLIC HERBST APPLIANCE is LRK.

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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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