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FDA 510(k)

IPS INLINE POM SYSTEM

K-Number: K071848 · 2007-08-30

ApplicantIvoclar Vivadent, Inc.
Decision Date2007-08-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS INLINE POM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2007-08-30 under 510(k) number K071848. 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 IPS INLINE POM SYSTEM?

IPS INLINE POM SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-30. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K071848.

When did IPS INLINE POM SYSTEM receive FDA 510(k) clearance?

IPS INLINE POM SYSTEM received FDA 510(k) clearance on 2007-08-30, under 510(k) number K071848.

Who is the listed applicant for IPS INLINE POM SYSTEM?

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

What is the FDA product code for IPS INLINE POM SYSTEM?

The FDA product code for IPS INLINE POM SYSTEM is EIH.

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Other records listing Ivoclar Vivadent, Inc. as applicant

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Related Devices (Code: EIH)

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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