Signature Orthodontic System
K-Number: K183542 · 2019-01-02
ApplicantSignature Orthodontics
Decision Date2019-01-02
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Signature Orthodontic System is a medical device manufactured by Signature Orthodontics. It received FDA 510(k) clearance on 2019-01-02 under approval number K183542. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Signature Orthodontic System?
Signature Orthodontic System is a medical device that received FDA 510(k) clearance on 2019-01-02. It is manufactured by Signature Orthodontics. The 510(k) number is K183542.
When was Signature Orthodontic System approved by the FDA?
Signature Orthodontic System received FDA 510(k) clearance on 2019-01-02, under approval number K183542.
What company makes Signature Orthodontic System?
Signature Orthodontic System is manufactured by Signature Orthodontics.
What is the FDA product code for Signature Orthodontic System?
The FDA product code for Signature Orthodontic System is NJM.
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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.