G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
K-Number: K153231 · 2016-07-06
ApplicantGC America, Inc.
Decision Date2016-07-06
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2016-07-06 under approval number K153231. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer?
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by GC America, Inc.. The 510(k) number is K153231.
When was G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer approved by the FDA?
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer received FDA 510(k) clearance on 2016-07-06, under approval number K153231.
What company makes G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer?
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer is manufactured by GC America, Inc..
What is the FDA product code for G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer?
The FDA product code for G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer is EMA.
Other Devices by GC America, Inc.
Related Devices (Code: EMA)
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.