FDA 510(k)

BIOPORTA G, MODEL 2052

K-Number: K012826 · 2001-11-01

Decision Date2001-11-01

Product CodeEJT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BIOPORTA G, MODEL 2052 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 K012826. 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 BIOPORTA G, MODEL 2052?

BIOPORTA G, MODEL 2052 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 K012826.

When did BIOPORTA G, MODEL 2052 receive FDA 510(k) clearance?

BIOPORTA G, MODEL 2052 received FDA 510(k) clearance on 2001-11-01, under 510(k) number K012826.

Who is the listed applicant for BIOPORTA G, MODEL 2052?

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 BIOPORTA G, MODEL 2052?

The FDA product code for BIOPORTA G, MODEL 2052 is EJT.

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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 K012828PORTA SMK 82, MODEL 2032 K012827PORTA AURIUM, MODEL 2067

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Related Devices (Code: EJT)

K052463PROMETAL HN86Prometal Technologies K041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KG K040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KG K040043NDX-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.