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FDA 510(k)

ORTHODONTIC BITE

K-Number: K922984 · 1993-03-31

ApplicantAmerican Orthodontics
Decision Date1993-03-31
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC BITE is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K922984. 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 ORTHODONTIC BITE?

ORTHODONTIC BITE is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is American Orthodontics. The 510(k) number is K922984.

When did ORTHODONTIC BITE receive FDA 510(k) clearance?

ORTHODONTIC BITE received FDA 510(k) clearance on 1993-03-31, under 510(k) number K922984.

Who is the listed applicant for ORTHODONTIC BITE?

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

What is the FDA product code for ORTHODONTIC BITE?

The FDA product code for ORTHODONTIC BITE is LRK.

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Other records listing American Orthodontics as applicant

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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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