Cleared Traditional

PF Keep; Cad Cam Keep Block

K233171 · Clemde SA DE CV · Dental
Nov 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K233171 is an FDA 510(k) clearance for the PF Keep; Cad Cam Keep Block, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Clemde SA DE CV (Mexico City, MX). The FDA issued a Cleared decision on November 27, 2023, 60 days after receiving the submission on September 28, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K233171 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date November 27, 2023
Days to Decision 60 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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