Obsidian® NOW
K-Number: K234014 · 2024-02-27
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2024-02-27
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Obsidian® NOW is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2024-02-27 under approval number K234014. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Obsidian® NOW?
Obsidian® NOW is a medical device that received FDA 510(k) clearance on 2024-02-27. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K234014.
When was Obsidian® NOW approved by the FDA?
Obsidian® NOW received FDA 510(k) clearance on 2024-02-27, under approval number K234014.
What company makes Obsidian® NOW?
Obsidian® NOW is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for Obsidian® NOW?
The FDA product code for Obsidian® NOW is EIH.
Other Devices by Prismatik Dentalcraft, Inc.
Related Devices (Code: EIH)
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.