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FDA 510(k)

CLEARSPLINT ES

K-Number: K111828 · 2011-10-26

ApplicantAstron Dental Corporation
Decision Date2011-10-26
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

CLEARSPLINT ES is the device name listed in this FDA 510(k) record. The listed applicant is Astron Dental Corporation. It received FDA 510(k) clearance on 2011-10-26 under 510(k) number K111828. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARSPLINT ES?

CLEARSPLINT ES is a medical device that received FDA 510(k) clearance on 2011-10-26. The listed applicant is Astron Dental Corporation. The 510(k) number is K111828.

When did CLEARSPLINT ES receive FDA 510(k) clearance?

CLEARSPLINT ES received FDA 510(k) clearance on 2011-10-26, under 510(k) number K111828.

Who is the listed applicant for CLEARSPLINT ES?

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

What is the FDA product code for CLEARSPLINT ES?

The FDA product code for CLEARSPLINT ES is MQC.

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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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