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FDA 510(k)

SILENT PARTNER SERIES OSA APPLIANCES

K-Number: K051014 · 2005-08-09

ApplicantDreamwrx Dental Laboratory
Decision Date2005-08-09
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILENT PARTNER SERIES OSA APPLIANCES is the device name listed in this FDA 510(k) record. The listed applicant is Dreamwrx Dental Laboratory. It received FDA 510(k) clearance on 2005-08-09 under 510(k) number K051014. 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 SILENT PARTNER SERIES OSA APPLIANCES?

SILENT PARTNER SERIES OSA APPLIANCES is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Dreamwrx Dental Laboratory. The 510(k) number is K051014.

When did SILENT PARTNER SERIES OSA APPLIANCES receive FDA 510(k) clearance?

SILENT PARTNER SERIES OSA APPLIANCES received FDA 510(k) clearance on 2005-08-09, under 510(k) number K051014.

Who is the listed applicant for SILENT PARTNER SERIES OSA APPLIANCES?

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

What is the FDA product code for SILENT PARTNER SERIES OSA APPLIANCES?

The FDA product code for SILENT PARTNER SERIES OSA APPLIANCES 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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