Cleared Traditional

K200175 - DIA-ROOT BIO Sealer

K200175 is an FDA 510(k) clearance for DIA-ROOT BIO Sealer, 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 154-day FDA review.

K200175 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
154d
Days
Class 2
Risk

K200175 is an FDA 510(k) clearance for the DIA-ROOT BIO Sealer. 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 25, 2020 after a review of 154 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 - K200175

510(k) Number K200175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2020
Decision Date June 25, 2020
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
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
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K200175.
EDS Bioceramic Sealer (Bioseal)
K202281 · Essential Dental Systems · Feb 2021
Bio-C Repair Ion+
K201222 · Angelus Industria DE Produtos Odontologicos S/A · Feb 2021
DIA-ROOT BIO MTA
K200174 · DiaDent Group International · Sep 2020
Diapaste
K190091 · DiaDent Group International · Mar 2020
BIO-C Sealer Ion+
K190537 · Angelus Industria DE Produtos Odontologicos S/A · Dec 2019
Dia-Proseal
K182009 · DiaDent Group International · Sep 2019