Cleared Traditional

K182625 - Diapex Plus

K182625 is an FDA 510(k) clearance for Diapex Plus, manufactured by DiaDent Group International. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K182625 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
252d
Days
Class 2
Risk

K182625 is an FDA 510(k) clearance for the Diapex Plus. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on June 3, 2019 after a review of 252 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 - K182625

510(k) Number K182625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date June 03, 2019
Days to Decision 252 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
125d slower than avg
Panel avg: 127d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 83
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BIO-C TEMP
K180199 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2019