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FDA 510(k)

RESTFUL NIGHTS, IST-APPLIANCE

K-Number: K021569 · 2004-03-15

ApplicantOttawa Dental Laboratory
Decision Date2004-03-15
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESTFUL NIGHTS, IST-APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Ottawa Dental Laboratory. It received FDA 510(k) clearance on 2004-03-15 under 510(k) number K021569. 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 RESTFUL NIGHTS, IST-APPLIANCE?

RESTFUL NIGHTS, IST-APPLIANCE is a medical device that received FDA 510(k) clearance on 2004-03-15. The listed applicant is Ottawa Dental Laboratory. The 510(k) number is K021569.

When did RESTFUL NIGHTS, IST-APPLIANCE receive FDA 510(k) clearance?

RESTFUL NIGHTS, IST-APPLIANCE received FDA 510(k) clearance on 2004-03-15, under 510(k) number K021569.

Who is the listed applicant for RESTFUL NIGHTS, IST-APPLIANCE?

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

What is the FDA product code for RESTFUL NIGHTS, IST-APPLIANCE?

The FDA product code for RESTFUL NIGHTS, IST-APPLIANCE is LRK.

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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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