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FDA 510(k)

MINIGOLD

K-Number: K905326 · 1990-12-24

ApplicantIvoclar North America, Inc.
Decision Date1990-12-24
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINIGOLD is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1990-12-24 under 510(k) number K905326. 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 MINIGOLD?

MINIGOLD is a medical device that received FDA 510(k) clearance on 1990-12-24. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K905326.

When did MINIGOLD receive FDA 510(k) clearance?

MINIGOLD received FDA 510(k) clearance on 1990-12-24, under 510(k) number K905326.

Who is the listed applicant for MINIGOLD?

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

What is the FDA product code for MINIGOLD?

The FDA product code for MINIGOLD is EJT.

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Other records listing Ivoclar North America, Inc. 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.

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Related Devices (Code: EJT)

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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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