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FDA 510(k)

HIGH GOLD PALLADIUM FREE CERAMIC SOLDER

K-Number: K012877 · 2001-11-21

ApplicantIvoclar USA, Inc.
Decision Date2001-11-21
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIGH GOLD PALLADIUM FREE CERAMIC SOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar USA, Inc.. It received FDA 510(k) clearance on 2001-11-21 under 510(k) number K012877. 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 HIGH GOLD PALLADIUM FREE CERAMIC SOLDER?

HIGH GOLD PALLADIUM FREE CERAMIC SOLDER is a medical device that received FDA 510(k) clearance on 2001-11-21. The listed applicant is Ivoclar USA, Inc.. The 510(k) number is K012877.

When did HIGH GOLD PALLADIUM FREE CERAMIC SOLDER receive FDA 510(k) clearance?

HIGH GOLD PALLADIUM FREE CERAMIC SOLDER received FDA 510(k) clearance on 2001-11-21, under 510(k) number K012877.

Who is the listed applicant for HIGH GOLD PALLADIUM FREE CERAMIC SOLDER?

The FDA 510(k) record lists Ivoclar USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGH GOLD PALLADIUM FREE CERAMIC SOLDER?

The FDA product code for HIGH GOLD PALLADIUM FREE CERAMIC SOLDER is EJT.

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Other records listing Ivoclar USA, Inc. as applicant

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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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