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FDA 510(k)

ERIS LAYERING MATERIALS

K-Number: K012174 · 2001-08-27

ApplicantIvoclar North America, Inc.
Decision Date2001-08-27
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ERIS LAYERING MATERIALS 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 2001-08-27 under 510(k) number K012174. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERIS LAYERING MATERIALS?

ERIS LAYERING MATERIALS is a medical device that received FDA 510(k) clearance on 2001-08-27. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K012174.

When did ERIS LAYERING MATERIALS receive FDA 510(k) clearance?

ERIS LAYERING MATERIALS received FDA 510(k) clearance on 2001-08-27, under 510(k) number K012174.

Who is the listed applicant for ERIS LAYERING MATERIALS?

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 ERIS LAYERING MATERIALS?

The FDA product code for ERIS LAYERING MATERIALS is EIH.

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Other records listing Ivoclar North America, Inc. as applicant

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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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