Cleared Traditional

K233868 - dima Print Teeth & Temp

K233868 is an FDA 510(k) clearance for dima Print Teeth & Temp, manufactured by Kulzer, LLC. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K233868

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.

EBG Device Classification - Class 2, Special Controls

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 160
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