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FDA 510(k)

PORTALLOY 54

K-Number: K021242 · 2002-05-16

ApplicantWieland Dental + Technik GmbH & Co. KG
Decision Date2002-05-16
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTALLOY 54 is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. It received FDA 510(k) clearance on 2002-05-16 under 510(k) number K021242. 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 PORTALLOY 54?

PORTALLOY 54 is a medical device that received FDA 510(k) clearance on 2002-05-16. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. The 510(k) number is K021242.

When did PORTALLOY 54 receive FDA 510(k) clearance?

PORTALLOY 54 received FDA 510(k) clearance on 2002-05-16, under 510(k) number K021242.

Who is the listed applicant for PORTALLOY 54?

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

What is the FDA product code for PORTALLOY 54?

The FDA product code for PORTALLOY 54 is EJT.

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Other records listing Wieland Dental + Technik GmbH & Co. KG 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.

K130184ZENOLUXK112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZRK103773ZENOFLEX DIMENSIONK103494ZENOSTAR MAGIC GLAZEK082257ZENO AI ECO DISCK080182ZENO PMMA DISC

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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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