Image Fast Set, Image Regular Set
K-Number: K160097 · 2016-08-05
ApplicantSybron Dental Specialties
Decision Date2016-08-05
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Image Fast Set, Image Regular Set is a medical device manufactured by Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-08-05 under approval number K160097. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Image Fast Set, Image Regular Set?
Image Fast Set, Image Regular Set is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by Sybron Dental Specialties. The 510(k) number is K160097.
When was Image Fast Set, Image Regular Set approved by the FDA?
Image Fast Set, Image Regular Set received FDA 510(k) clearance on 2016-08-05, under approval number K160097.
What company makes Image Fast Set, Image Regular Set?
Image Fast Set, Image Regular Set is manufactured by Sybron Dental Specialties.
What is the FDA product code for Image Fast Set, Image Regular Set?
The FDA product code for Image Fast Set, Image Regular Set is ELW.
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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.