FDA 510(k)

ZRP

K-Number: K131049 · 2013-08-27

Decision Date2013-08-27

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZRP is the device name listed in this FDA 510(k) record. The listed applicant is Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2013-08-27 under 510(k) number K131049. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZRP?

ZRP is a medical device that received FDA 510(k) clearance on 2013-08-27. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K131049.

When did ZRP receive FDA 510(k) clearance?

ZRP received FDA 510(k) clearance on 2013-08-27, under 510(k) number K131049.

Who is the listed applicant for ZRP?

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

What is the FDA product code for ZRP?

The FDA product code for ZRP is KLE.

Other records listing Apex Dental Materials, 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: KLE)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.