Cleared Traditional

K213401 - DIAPLUS Universal

K213401 is an FDA 510(k) clearance for DIAPLUS Universal, manufactured by DiaDent Group International. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K213401 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
105d
Days
Class 2
Risk

K213401 is an FDA 510(k) clearance for the DIAPLUS Universal. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on January 31, 2022 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 DiaDent Group International devices

FDA 510(k) Submission Details - K213401

510(k) Number K213401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2021
Decision Date January 31, 2022
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K213401.
Dia-X Bond Universal
K220804 · DiaDent Group International · Jun 2022
Adhese Universal DC, Cention Primer
K210804 · Ivoclar Vivadent, AG · Jun 2022
BeautiBond Xtreme
K213965 · Shofu Dental Corporation · Mar 2022
STEP-1 PumEtch
K213093 · Rounding Third, LLC · Jan 2022
PacBond One
K210186 · Pac-Dent, Inc. · Jul 2021
Ultra SEP
K210945 · Reliance Orthodontic Products, Inc. · Jul 2021