Cleared Traditional

Flexible Partial Resin

K250302 · Prismatik Dentalcraft, Inc. · Dental
Jun 2025
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K250302 is an FDA 510(k) clearance for the Flexible Partial Resin, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on June 25, 2025, 142 days after receiving the submission on February 3, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K250302 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2025
Decision Date June 25, 2025
Days to Decision 142 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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