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FDA 510(k)

PORTA AURIUM, MODEL 2067

K-Number: K012827 · 2001-11-01

ApplicantWieland Edelmetalle GmbH & Co.
Decision Date2001-11-01
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTA AURIUM, MODEL 2067 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 K012827. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA AURIUM, MODEL 2067?

PORTA AURIUM, MODEL 2067 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 K012827.

When did PORTA AURIUM, MODEL 2067 receive FDA 510(k) clearance?

PORTA AURIUM, MODEL 2067 received FDA 510(k) clearance on 2001-11-01, under 510(k) number K012827.

Who is the listed applicant for PORTA AURIUM, MODEL 2067?

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 AURIUM, MODEL 2067?

The FDA product code for PORTA AURIUM, MODEL 2067 is EJT.

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Other records listing Wieland Edelmetalle GmbH & Co. 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.

K020347AGC SPEZIALLEGIERUNGK012839AUROPAL, ORDER-NO.: 2101K012841DUO PAL 6, ORDER-NO.: 2154K012843PORTADUR P 2, MODEL #2031K012834PORTA GEO TI MODEL #2004K012828PORTA SMK 82, MODEL 2032

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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