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FDA 510(k)

SOMNOBRUX SPLINTS

K-Number: K102909 · 2011-12-13

ApplicantSomnomed, Inc.
Decision Date2011-12-13
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

SOMNOBRUX SPLINTS is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2011-12-13 under 510(k) number K102909. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNOBRUX SPLINTS?

SOMNOBRUX SPLINTS is a medical device that received FDA 510(k) clearance on 2011-12-13. The listed applicant is Somnomed, Inc.. The 510(k) number is K102909.

When did SOMNOBRUX SPLINTS receive FDA 510(k) clearance?

SOMNOBRUX SPLINTS received FDA 510(k) clearance on 2011-12-13, under 510(k) number K102909.

Who is the listed applicant for SOMNOBRUX SPLINTS?

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

What is the FDA product code for SOMNOBRUX SPLINTS?

The FDA product code for SOMNOBRUX SPLINTS is MQC.

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Other records listing Somnomed, Inc. 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.

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Related Devices (Code: MQC)

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.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, 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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