RnD TE and RnD SE
K-Number: K161077 · 2017-03-17
ApplicantApex Dental Materials, Inc.
Decision Date2017-03-17
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
RnD TE and RnD SE is a medical device manufactured by Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2017-03-17 under approval 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. It is manufactured by Apex Dental Materials, Inc.. The 510(k) number is K161077.
When was RnD TE and RnD SE approved by the FDA?
RnD TE and RnD SE received FDA 510(k) clearance on 2017-03-17, under approval number K161077.
What company makes RnD TE and RnD SE?
RnD TE and RnD SE is manufactured by Apex Dental Materials, Inc..
What is the FDA product code for RnD TE and RnD SE?
The FDA product code for RnD TE and RnD SE is KLE.
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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.