FDA 510(k)

EURO 45, ORDER-NO.: 2064

K-Number: K012840 · 2001-10-23

Decision Date2001-10-23

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EURO 45, ORDER-NO.: 2064 is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Edelmetalle GmbH & Co.. It received FDA 510(k) clearance on 2001-10-23 under 510(k) number K012840. 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 EURO 45, ORDER-NO.: 2064?

EURO 45, ORDER-NO.: 2064 is a medical device that received FDA 510(k) clearance on 2001-10-23. The listed applicant is Wieland Edelmetalle GmbH & Co.. The 510(k) number is K012840.

When did EURO 45, ORDER-NO.: 2064 receive FDA 510(k) clearance?

EURO 45, ORDER-NO.: 2064 received FDA 510(k) clearance on 2001-10-23, under 510(k) number K012840.

Who is the listed applicant for EURO 45, ORDER-NO.: 2064?

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

What is the FDA product code for EURO 45, ORDER-NO.: 2064?

The FDA product code for EURO 45, ORDER-NO.: 2064 is EJS.

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Other records listing Wieland Edelmetalle GmbH & Co. as applicant

K020347AGC SPEZIALLEGIERUNG K012839AUROPAL, ORDER-NO.: 2101 K012841DUO PAL 6, ORDER-NO.: 2154 K012843PORTADUR P 2, MODEL #2031 K012827PORTA AURIUM, MODEL 2067 K012828PORTA SMK 82, MODEL 2032

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Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR S1SWieland 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.