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FDA 510(k)

EOS IMPRESSION TRAYS

K-Number: K896470 · 1990-02-09

ApplicantIvoclar North America, Inc.
Decision Date1990-02-09
Product CodeEHY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EOS IMPRESSION TRAYS 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 1990-02-09 under 510(k) number K896470. The device is classified under product code EHY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EOS IMPRESSION TRAYS?

EOS IMPRESSION TRAYS is a medical device that received FDA 510(k) clearance on 1990-02-09. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K896470.

When did EOS IMPRESSION TRAYS receive FDA 510(k) clearance?

EOS IMPRESSION TRAYS received FDA 510(k) clearance on 1990-02-09, under 510(k) number K896470.

Who is the listed applicant for EOS IMPRESSION TRAYS?

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 EOS IMPRESSION TRAYS?

The FDA product code for EOS IMPRESSION TRAYS is EHY.

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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: EHY)

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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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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