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FDA 510(k)

ECO E4

K-Number: K022469 · 2002-09-18

ApplicantWieland Dental + Technik GmbH & Co. KG
Decision Date2002-09-18
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ECO E4 is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. It received FDA 510(k) clearance on 2002-09-18 under 510(k) number K022469. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECO E4?

ECO E4 is a medical device that received FDA 510(k) clearance on 2002-09-18. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. The 510(k) number is K022469.

When did ECO E4 receive FDA 510(k) clearance?

ECO E4 received FDA 510(k) clearance on 2002-09-18, under 510(k) number K022469.

Who is the listed applicant for ECO E4?

The FDA 510(k) record lists Wieland Dental + Technik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECO E4?

The FDA product code for ECO E4 is EJS.

Other records listing Wieland Dental + Technik GmbH & Co. KG 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.

K130184ZENOLUXK112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZRK103773ZENOFLEX DIMENSIONK103494ZENOSTAR MAGIC GLAZEK082257ZENO AI ECO DISCK080182ZENO PMMA DISC

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK021367STERNGOLD 66, MODEL #1180230SterngoldK020192SIMIDUR S2Wieland Dental + Technik GmbH & Co. KGK020194SIMIDUR KF PLUSWieland Dental + Technik GmbH & Co. KG

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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