Cleared Traditional

K192392 - DiaPlus

K192392 is an FDA 510(k) clearance for DiaPlus, 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 266-day FDA review.

K192392 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
266d
Days
Class 2
Risk

K192392 is an FDA 510(k) clearance for the DiaPlus. 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 May 26, 2020 after a review of 266 days - an extended review cycle.

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 - K192392

510(k) Number K192392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date May 26, 2020
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
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 K192392.
BZF-29
K200682 · GC America, Inc. · Oct 2020
Light Cure Dental Adhesive
K201787 · Rizhao Huge Biomaterials Company, Ltd. · Sep 2020
EtchPro Etching Gel
K200462 · Belport Company, Inc., Gingi-Pak · Sep 2020
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
K192273 · DiaDent Group International · Feb 2020
Ambar, Ambar APS, Ambar Universal APS
K183424 · Dentscare Ltda · Dec 2019
Zipbond
K191656 · Sdi Limited · Dec 2019