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FDA 510(k)

SLEEPBITE

K-Number: K013808 · 2002-01-30

ApplicantDental Imagineers, LLC
Decision Date2002-01-30
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SLEEPBITE is the device name listed in this FDA 510(k) record. The listed applicant is Dental Imagineers, LLC. It received FDA 510(k) clearance on 2002-01-30 under 510(k) number K013808. 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 SLEEPBITE?

SLEEPBITE is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Dental Imagineers, LLC. The 510(k) number is K013808.

When did SLEEPBITE receive FDA 510(k) clearance?

SLEEPBITE received FDA 510(k) clearance on 2002-01-30, under 510(k) number K013808.

Who is the listed applicant for SLEEPBITE?

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

What is the FDA product code for SLEEPBITE?

The FDA product code for SLEEPBITE is LRK.

Related Clinical Trials

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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Other records listing Dental Imagineers, LLC as applicant

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.

K022284SNORE-AID MAXK991449SNORE-AID PLUS

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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