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FDA 510(k)

O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)

K-Number: K060744 · 2006-06-02

ApplicantO'Brien Dental Lab, Inc.
Decision Date2006-06-02
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) is the device name listed in this FDA 510(k) record. The listed applicant is O'Brien Dental Lab, Inc.. It received FDA 510(k) clearance on 2006-06-02 under 510(k) number K060744. 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 O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)?

O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) is a medical device that received FDA 510(k) clearance on 2006-06-02. The listed applicant is O'Brien Dental Lab, Inc.. The 510(k) number is K060744.

When did O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) receive FDA 510(k) clearance?

O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) received FDA 510(k) clearance on 2006-06-02, under 510(k) number K060744.

Who is the listed applicant for O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)?

The FDA 510(k) record lists O'Brien Dental Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)?

The FDA product code for O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) 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.

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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