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Serenocem Model BC 010

by Corinthian Medical, Ltd.

510(k) K003567

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003567 Date12 Feb 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NEA
FDA applicant
Corinthian Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Serenocem Model BC 010 is a dental cement designed for use in ear, nose, and throat (ENT) procedures. It is classified as a Class II medical device under FDA regulations and falls under the product code NEA, intended for applications requiring durable, biocompatible filling materials in oral and maxillofacial surgery.

This device is supplied as a reusable or single-use material, depending on clinical protocol, and is regulated under FDA 510(k) clearance (K003567) with a decision date of February 12, 2001. It is intended for use in dental settings, adhering to sterility standards required for surgical applications. The device is not MRI-safe, and its storage and handling must comply with standard medical device protocols for biocompatible materials.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical procedures is the Serenocem Model BC 010 dental cement primarily used for?

    The Serenocem Model BC 010 is specifically designed for use in ear, nose, and throat (ENT) procedures within dental and maxillofacial surgery. It serves as a durable, biocompatible filling material, particularly in applications requiring long-lasting support or restoration in oral and ENT-related surgeries.

  • Is the Serenocem Model BC 010 intended for single-use or reusable applications, and how should it be handled?

    The Serenocem Model BC 010 can be used either as a single-use or reusable material, depending on the clinical protocol followed. Since it is intended for surgical applications, it must be handled and stored according to standard sterility protocols for medical devices to ensure patient safety and compliance with regulatory requirements.

  • What storage and handling precautions should be taken for the Serenocem Model BC 010?

    The Serenocem Model BC 010 must be stored and handled in compliance with standard medical device protocols for biocompatible materials. While it is not explicitly stated to be MRI-safe, its storage should follow general guidelines for surgical-grade materials to maintain sterility and integrity until use.

  • What regulatory pathway was followed for the FDA clearance of the Serenocem Model BC 010?

    The Serenocem Model BC 010 received FDA clearance through a traditional 510(k) process, classified as substantially equivalent under the product code NEA. It was reviewed by the Dental (DE) advisory committee and received clearance on February 12, 2001, under the registration number K003567.