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FDA 510(k)

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS

K-Number: K994435 · 2000-02-10

ApplicantJeneric/Pentron, Inc.
Decision Date2000-02-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K994435. 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 OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS?

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K994435.

When did OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS receive FDA 510(k) clearance?

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS received FDA 510(k) clearance on 2000-02-10, under 510(k) number K994435.

Who is the listed applicant for OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS?

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

What is the FDA product code for OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS?

The FDA product code for OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS is EIH.

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Other records listing Jeneric/Pentron, Inc. as applicant

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Related Devices (Code: EIH)

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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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