Cleared Traditional

K202281 - EDS Bioceramic Sealer (Bioseal)

K202281 is an FDA 510(k) clearance for EDS Bioceramic Sealer (Bioseal), manufactured by Essential Dental Systems. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K202281 · Essential Dental Systems · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K202281

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.

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 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