FDA 510(k)

E-Guard

K-Number: K201173 · 2020-11-27

Decision Date2020-11-27

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

E-Guard is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2020-11-27 under 510(k) number K201173. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Guard?

E-Guard is a medical device that received FDA 510(k) clearance on 2020-11-27. The listed applicant is Envisiontec GmbH. The 510(k) number is K201173.

When did E-Guard receive FDA 510(k) clearance?

E-Guard received FDA 510(k) clearance on 2020-11-27, under 510(k) number K201173.

Who is the listed applicant for E-Guard?

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

What is the FDA product code for E-Guard?

The FDA product code for E-Guard is MQC.

Other records listing Envisiontec GmbH 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.

K220894SmileGuard K211101E-Temp K210977E-Dent 1000 K203641E-Denture Pro

Related Devices (Code: MQC)

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

View on FDA Database →

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