Cleared Abbreviated

K190537 - BIO-C Sealer Ion+ (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K190537 · Angelus Industria DE Produtos Odontologicos S/A · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2019
Decision
283d
Days
Class 2
Risk

K190537 is an FDA 510(k) clearance for the BIO-C Sealer Ion+. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Angelus Industria DE Produtos Odontologicos S/A (Londrina, BR). The FDA issued a Cleared decision on December 12, 2019 after a review of 283 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Angelus Industria DE Produtos Odontologicos S/A devices

Submission Details

510(k) Number K190537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date December 12, 2019
Days to Decision 283 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 127d · This submission: 283d
Pathway characteristics
Standards-based clearance path.

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

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