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FDA 510(k)

SLEEP SPLINT

K-Number: K060122 · 2006-05-19

ApplicantNakagawa Dental Clinic
Decision Date2006-05-19
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SLEEP SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Nakagawa Dental Clinic. It received FDA 510(k) clearance on 2006-05-19 under 510(k) number K060122. 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 SLEEP SPLINT?

SLEEP SPLINT is a medical device that received FDA 510(k) clearance on 2006-05-19. The listed applicant is Nakagawa Dental Clinic. The 510(k) number is K060122.

When did SLEEP SPLINT receive FDA 510(k) clearance?

SLEEP SPLINT received FDA 510(k) clearance on 2006-05-19, under 510(k) number K060122.

Who is the listed applicant for SLEEP SPLINT?

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

What is the FDA product code for SLEEP SPLINT?

The FDA product code for SLEEP SPLINT 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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