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FDA 510(k)

THE QUIET SLEEPER

K-Number: K012142 · 2001-10-04

ApplicantPrecision Dental Laboratories, Inc.
Decision Date2001-10-04
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE QUIET SLEEPER is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dental Laboratories, Inc.. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K012142. 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 THE QUIET SLEEPER?

THE QUIET SLEEPER is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Precision Dental Laboratories, Inc.. The 510(k) number is K012142.

When did THE QUIET SLEEPER receive FDA 510(k) clearance?

THE QUIET SLEEPER received FDA 510(k) clearance on 2001-10-04, under 510(k) number K012142.

Who is the listed applicant for THE QUIET SLEEPER?

The FDA 510(k) record lists Precision Dental Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE QUIET SLEEPER?

The FDA product code for THE QUIET SLEEPER 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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