Cleared Traditional

dima Print Teeth & Temp

K233868 · Kulzer, LLC · Dental
May 2024
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K233868 is an FDA 510(k) clearance for the dima Print Teeth & Temp, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on May 23, 2024, 169 days after receiving the submission on December 6, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K233868 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2023
Decision Date May 23, 2024
Days to Decision 169 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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