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Bio-C Sealer Ion+

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190537

by Angelus Industria de Produtos Odontologicos S A

Identifiers

510(k) Number
K190537 FDA 510(k)
FDA Product Code
KIF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3820 FDA 510(k)
Regulation Number
872.3820 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bio-C Sealer Ion+ is a Resin, Root Canal Filling Material (per FDA nomenclature), designed for obturation of root canals during endodontic therapy. It combines radiopacity, biocompatibility, and flowable properties to seal the root canal system effectively, reducing the risk of periapical pathology.

This device is supplied as a single-use, sterile, pre-filled syringe system for dental use. It is classified as Class II under FDA regulations (872.3820) and has received FDA 510K clearance and MDR authorization. Storage requires protection from extreme temperatures and direct sunlight, adhering to standard dental instrument protocols.

Frequently asked questions

What is the Bio-C Sealer Ion+ specifically designed to do in endodontic procedures?

The Bio-C Sealer Ion+ is a resin-based root canal filling material designed to seal the root canal system during endodontic therapy. Its key features include radiopacity (visible on X-rays), biocompatibility (safe for surrounding tissues), and flowable properties, which help reduce the risk of periapical pathology by ensuring a tight seal.

How is the Bio-C Sealer Ion+ supplied, and is it reusable?

The Bio-C Sealer Ion+ is supplied as a single-use, sterile, pre-filled syringe system specifically for dental use. This design ensures sterility and convenience while eliminating the need for reuse, which could compromise clinical safety.

What storage conditions are required for the Bio-C Sealer Ion+ to maintain its integrity?

The Bio-C Sealer Ion+ must be stored protected from extreme temperatures and direct sunlight. Following standard dental instrument protocols helps preserve its performance and sterility until use.

Does the Bio-C Sealer Ion+ come in multiple sizes or models, and if so, how are they differentiated?

The provided data does not specify distinct sizes or models for the Bio-C Sealer Ion+. However, the device is listed under multiple registration numbers (e.g., 3002807757, 3003120666), which may correspond to variations in packaging or batch identifiers rather than clinical sizes. For precise sizing details, refer to the manufacturer’s packaging or technical documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Angelus Industria de Produtos Odontologicos S A
FDA Applicant
Angelus Industria DE Produtos Odontologicos S/A

Sources (2)

  • FDA 510(k) K190537 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026