Glidewell 3DP Denture Base Resin
K-Number: K213765 · 2022-06-22
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2022-06-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Glidewell 3DP Denture Base Resin is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2022-06-22 under approval number K213765. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Glidewell 3DP Denture Base Resin?
Glidewell 3DP Denture Base Resin is a medical device that received FDA 510(k) clearance on 2022-06-22. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K213765.
When was Glidewell 3DP Denture Base Resin approved by the FDA?
Glidewell 3DP Denture Base Resin received FDA 510(k) clearance on 2022-06-22, under approval number K213765.
What company makes Glidewell 3DP Denture Base Resin?
Glidewell 3DP Denture Base Resin is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for Glidewell 3DP Denture Base Resin?
The FDA product code for Glidewell 3DP Denture Base Resin is EBI.
Other Devices by Prismatik Dentalcraft, Inc.
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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.