FDA 510(k)

Thermoforming Sheet Materials

K-Number: K200125 · 2020-10-28

Decision Date2020-10-28

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

Thermoforming Sheet Materials is the device name listed in this FDA 510(k) record. The listed applicant is Erkodent Erich Kopp GmbH. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K200125. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermoforming Sheet Materials?

Thermoforming Sheet Materials is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Erkodent Erich Kopp GmbH. The 510(k) number is K200125.

When did Thermoforming Sheet Materials receive FDA 510(k) clearance?

Thermoforming Sheet Materials received FDA 510(k) clearance on 2020-10-28, under 510(k) number K200125.

Who is the listed applicant for Thermoforming Sheet Materials?

The FDA 510(k) record lists Erkodent Erich Kopp GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermoforming Sheet Materials?

The FDA product code for Thermoforming Sheet Materials 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.