Cleared Traditional

EDS Bioceramic Sealer (Bioseal) (K202281) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202281 · Essential Dental Systems · Dental device
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Feb 2021
Decision
184d
Days
Class 2
Risk

K202281 is an FDA 510(k) clearance for the EDS Bioceramic Sealer (Bioseal). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Essential Dental Systems (South Hackensack, US). The FDA issued a Cleared decision on February 12, 2021 after a review of 184 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 Essential Dental Systems devices

Submission Details

510(k) Number K202281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2020
Decision Date February 12, 2021
Days to Decision 184 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
57d slower than avg
Panel avg: 127d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K202281.
Metapex Plus
K202617 · Meta Biomed Co., Ltd. · Apr 2021
DiaPaste
K210333 · DiaDent Group International · Mar 2021
White ENDOSEAL MTA
K202015 · Maruchi · Mar 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
DIA-ROOT BIO Sealer
K200175 · DiaDent Group International · Jun 2020