Ormco Spark Aligner System
K-Number: K182826 · 2018-10-11
ApplicantSybron Dental Specialties
Decision Date2018-10-11
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Ormco Spark Aligner System is a medical device manufactured by Sybron Dental Specialties. It received FDA 510(k) clearance on 2018-10-11 under approval number K182826. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ormco Spark Aligner System?
Ormco Spark Aligner System is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Sybron Dental Specialties. The 510(k) number is K182826.
When was Ormco Spark Aligner System approved by the FDA?
Ormco Spark Aligner System received FDA 510(k) clearance on 2018-10-11, under approval number K182826.
What company makes Ormco Spark Aligner System?
Ormco Spark Aligner System is manufactured by Sybron Dental Specialties.
What is the FDA product code for Ormco Spark Aligner System?
The FDA product code for Ormco Spark Aligner System is NXC.
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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.