enCore Impression Material
K-Number: K251926 · 2026-03-17
ApplicantEncore Guards
Decision Date2026-03-17
Product CodeSHI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
enCore Impression Material is a medical device manufactured by Encore Guards. It received FDA 510(k) clearance on 2026-03-17 under approval number K251926. The device is classified under product code SHI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the enCore Impression Material?
enCore Impression Material is a medical device that received FDA 510(k) clearance on 2026-03-17. It is manufactured by Encore Guards. The 510(k) number is K251926.
When was enCore Impression Material approved by the FDA?
enCore Impression Material received FDA 510(k) clearance on 2026-03-17, under approval number K251926.
What company makes enCore Impression Material?
enCore Impression Material is manufactured by Encore Guards.
What is the FDA product code for enCore Impression Material?
The FDA product code for enCore Impression Material is SHI.
Other Devices by Encore Guards
Related Devices (Code: SHI)
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.