Link Abutment for CEREC
K-Number: K160519 · 2016-10-28
ApplicantOsstem Implant Co., Ltd.
Decision Date2016-10-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Link Abutment for CEREC is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2016-10-28 under approval number K160519. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Link Abutment for CEREC?
Link Abutment for CEREC is a medical device that received FDA 510(k) clearance on 2016-10-28. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K160519.
When was Link Abutment for CEREC approved by the FDA?
Link Abutment for CEREC received FDA 510(k) clearance on 2016-10-28, under approval number K160519.
What company makes Link Abutment for CEREC?
Link Abutment for CEREC is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for Link Abutment for CEREC?
The FDA product code for Link Abutment for CEREC is NHA.
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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.