Cleared Traditional

K233868 - dima Print Teeth & Temp

K233868 is the FDA 510(k) clearance for dima Print Teeth & Temp by Kulzer, LLC. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K233868 · Kulzer, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
169d
Days
Class 2
Risk

K233868 is an FDA 510(k) clearance for the dima Print Teeth & Temp. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on May 23, 2024 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kulzer, LLC devices

Submission Details

510(k) Number K233868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 109
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K233868.
Digital Temp
K242559 · Sprintray, Inc. · Nov 2024
Premium Teeth Resin
K240538 · Formlabs Ohio, Inc. · Jul 2024
Fixtemp® C&B 4:1
K241226 · Dreve Denatmid GmbH · May 2024
PMMA BLOCK
K223706 · Huliang(Shanghai) Bio-Tech Co., Ltd. · May 2023
PMMA Blocks for Dental Use
K223477 · Aidite (Qinhuangdao) Technology Co., Ltd. · Feb 2023
CURA-Temp
K202965 · Mgnewton , Ltd. · Dec 2022