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FDA 510(k)

Flexible Partial Resin

K-Number: K250302 · 2025-06-25

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2025-06-25
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Flexible Partial Resin is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2025-06-25 under approval number K250302. 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 Flexible Partial Resin?

Flexible Partial Resin is a medical device that received FDA 510(k) clearance on 2025-06-25. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K250302.

When was Flexible Partial Resin approved by the FDA?

Flexible Partial Resin received FDA 510(k) clearance on 2025-06-25, under approval number K250302.

What company makes Flexible Partial Resin?

Flexible Partial Resin is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for Flexible Partial Resin?

The FDA product code for Flexible Partial Resin is EBI.

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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.

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