Cleared Traditional

Ivotion Base Print

K233995 · Ivoclar Vivadent, Inc. · Dental
Feb 2024
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K233995 is an FDA 510(k) clearance for the Ivotion Base Print, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on February 23, 2024, 67 days after receiving the submission on December 18, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K233995 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2023
Decision Date February 23, 2024
Days to Decision 67 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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