FDA 510(k)

PORTA SMK 82, MODEL 2032

K-Number: K012828 · 2001-11-01

Decision Date2001-11-01

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PORTA SMK 82, MODEL 2032 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 2001-11-01 under 510(k) number K012828. 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 PORTA SMK 82, MODEL 2032?

PORTA SMK 82, MODEL 2032 is a medical device that received FDA 510(k) clearance on 2001-11-01. The listed applicant is Wieland Edelmetalle GmbH & Co.. The 510(k) number is K012828.

When did PORTA SMK 82, MODEL 2032 receive FDA 510(k) clearance?

PORTA SMK 82, MODEL 2032 received FDA 510(k) clearance on 2001-11-01, under 510(k) number K012828.

Who is the listed applicant for PORTA SMK 82, MODEL 2032?

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 PORTA SMK 82, MODEL 2032?

The FDA product code for PORTA SMK 82, MODEL 2032 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 K012834PORTA GEO TI MODEL #2004 K012827PORTA AURIUM, MODEL 2067

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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.