FDA 510(k)

RnD TE and RnD SE

K-Number: K161077 · 2017-03-17

Decision Date2017-03-17

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

RnD TE and RnD SE 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 2017-03-17 under 510(k) number K161077. 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 RnD TE and RnD SE?

RnD TE and RnD SE is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K161077.

When did RnD TE and RnD SE receive FDA 510(k) clearance?

RnD TE and RnD SE received FDA 510(k) clearance on 2017-03-17, under 510(k) number K161077.

Who is the listed applicant for RnD TE and RnD SE?

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 RnD TE and RnD SE?

The FDA product code for RnD TE and RnD SE 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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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.