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Bio-C Repair Ion+

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201222

by Angelus Industria de Produtos Odontologicos S A

Identifiers

510(k) Number
K201222 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 Repair Ion+ is a Resin, Root Canal Filling (per FDA nomenclature, regulation number 872.3820), designed for use in endodontic procedures. It is a composite material intended to fill and seal the root canal system, providing structural support and biological compatibility during dental restoration.

This device is supplied as a single-use resin system, requiring mixing and application by dental professionals in a clinical setting. It is sterile upon packaging and must be stored according to manufacturer instructions to maintain integrity. Authorised under FDA 510K (K201222) and MDR, it adheres to Class II regulatory standards for dental materials. No MRI safety information is specified.

Frequently asked questions

What is the Bio-C Repair Ion+ used for in dental procedures?

The Bio-C Repair Ion+ is a composite resin designed specifically for filling and sealing the root canal system during endodontic procedures. It provides structural support to the treated tooth while ensuring biological compatibility with surrounding tissues, helping to restore the tooth’s integrity after root canal therapy.

Is the Bio-C Repair Ion+ intended for single-use or can it be reused?

The Bio-C Repair Ion+ is supplied as a single-use resin system. It requires mixing and application by dental professionals in a clinical setting, meaning each package is intended for one procedure only.

How should the Bio-C Repair Ion+ be stored to maintain its integrity?

The Bio-C Repair Ion+ is sterile upon packaging, but it must be stored according to the manufacturer’s instructions to preserve its sterility and performance. Proper storage conditions are critical to maintaining the material’s integrity before use.

What regulatory pathways has the Bio-C Repair Ion+ followed for approval?

The Bio-C Repair Ion+ has been authorized through the FDA’s 510(k) pathway (K201222) and the EU’s Medical Device Regulation (MDR). It is classified as a Class II device under both regulatory frameworks, adhering to standards for dental materials.

Are there different sizes or models of the Bio-C Repair Ion+ available?

The provided data lists multiple registration numbers (e.g., 3002807757, 3003120666) under the product code KIF, which may correspond to different sizes or variants of the Bio-C Repair Ion+. However, specific size or model distinctions (e.g., incremental diameters or lengths) are not detailed in the data. Contacting the manufacturer would clarify available options.

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) K201222 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026