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FDA 510(k)

AUROPAL, ORDER-NO.: 2101

K-Number: K012839 · 2001-12-31

ApplicantWieland Edelmetalle GmbH & Co.
Decision Date2001-12-31
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUROPAL, ORDER-NO.: 2101 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 2001-12-31 under 510(k) number K012839. 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 AUROPAL, ORDER-NO.: 2101?

AUROPAL, ORDER-NO.: 2101 is a medical device that received FDA 510(k) clearance on 2001-12-31. The listed applicant is Wieland Edelmetalle GmbH & Co.. The 510(k) number is K012839.

When did AUROPAL, ORDER-NO.: 2101 receive FDA 510(k) clearance?

AUROPAL, ORDER-NO.: 2101 received FDA 510(k) clearance on 2001-12-31, under 510(k) number K012839.

Who is the listed applicant for AUROPAL, ORDER-NO.: 2101?

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 AUROPAL, ORDER-NO.: 2101?

The FDA product code for AUROPAL, ORDER-NO.: 2101 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 SPEZIALLEGIERUNGK012841DUO PAL 6, ORDER-NO.: 2154K012843PORTADUR P 2, MODEL #2031K012834PORTA GEO TI MODEL #2004K012827PORTA AURIUM, MODEL 2067K012828PORTA 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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