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Butler Nucare Root Conditioner with NovaMin

by Novamin Technology, Inc.

510(k) K033295

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033295 Date28 Oct 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
LBH
Device Class
Class II
Regulation
21 CFR Part 872.3260
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.

Butler Nucare Root Conditioner with NovaMin is a two-phase aqueous suspension containing bioactive glass (calcium sodium phosphosilicate). It is applied to exposed tooth root dentin by a dental professional to react with the aqueous environment, physically adhering to dentin and occluding dentinal tubules.

This device is supplied as a dental product and is regulated under FDA 510(k) clearance with product code LBH. It is classified as a Class II device for use in dental procedures, with the specific regulation number 872.3260, and was determined to be substantially equivalent to predicate devices.

Other devices from Novamin Technology, Inc.

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 is the Butler Nucare Root Conditioner with NovaMin used for?

    It is a two-phase aqueous suspension containing bioactive glass that dental professionals apply to exposed tooth root dentin to react with the aqueous environment, physically adhering to dentin and occluding dentinal tubules.

  • How is the Butler Nucare Root Conditioner supplied?

    It is supplied as a dental product in a two-phase aqueous suspension formulation that requires preparation by a dental professional before application to exposed tooth root dentin.

  • What is the regulatory classification of this device?

    It is classified as a Class II device under FDA 510(k) clearance with product code LBH, regulation number 872.3260, and was determined to be substantially equivalent to predicate devices.

  • Is the Butler Nucare Root Conditioner sterile?

    The device data does not specify sterility information, so it cannot be determined from the provided information whether the product is supplied sterile.

  • Can the Butler Nucare Root Conditioner be reused?

    The device data does not specify whether this product is single-use or reusable, so this information cannot be determined from the provided details.