Redline
K-Number: K213297 · 2022-02-09
ApplicantJohns Dental Laboratories
Decision Date2022-02-09
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Redline is a medical device manufactured by Johns Dental Laboratories. It received FDA 510(k) clearance on 2022-02-09 under approval number K213297. 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 Redline?
Redline is a medical device that received FDA 510(k) clearance on 2022-02-09. It is manufactured by Johns Dental Laboratories. The 510(k) number is K213297.
When was Redline approved by the FDA?
Redline received FDA 510(k) clearance on 2022-02-09, under approval number K213297.
What company makes Redline?
Redline is manufactured by Johns Dental Laboratories.
What is the FDA product code for Redline?
The FDA product code for Redline is NXC.
Related Devices (Code: NXC)
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.