FDA 510(k)

Urbanek Device

K-Number: K170985 · 2017-09-25

Decision Date2017-09-25

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

Urbanek Device is the device name listed in this FDA 510(k) record. The listed applicant is Tmj Services, LLC. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K170985. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Urbanek Device?

Urbanek Device is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Tmj Services, LLC. The 510(k) number is K170985.

When did Urbanek Device receive FDA 510(k) clearance?

Urbanek Device received FDA 510(k) clearance on 2017-09-25, under 510(k) number K170985.

Who is the listed applicant for Urbanek Device?

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

What is the FDA product code for Urbanek Device?

The FDA product code for Urbanek Device is MQC.

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 NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.