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Oravive Tooth Revitalizing Paste

by Novamin Technology, Inc.

510(k) K040473

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 NumberK040473 Date10 Mar 2004ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

ORAVIVE TOOTH REVITALIZING PASTE is a fluoride-free, non-aqueous toothpaste containing NovaMin® (calcium sodium phosphosilicate). It is designed for daily home use by patients to clean teeth and manage dentin hypersensitivity by depositing a calcium phosphate layer onto the tooth surface to occlude dentinal tubules and block hydrodynamic flow.

The device is supplied as a toothpaste for over-the-counter consumer use in a home setting. It is a single-use product per application, non-sterile, and not evaluated for MRI safety. The product has received FDA 510(k) clearance under K040473 with product code LBH and regulation number 872.3260, and is classified as a Class II medical device.

Other devices from Novamin Technology, Inc.

Questions

AI-generated answers, 26 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 ORAVIVE TOOTH REVITALIZING PASTE used for?

    ORAVIVE TOOTH REVITALIZING PASTE is designed for daily home use by patients to clean teeth and manage dentin hypersensitivity. It works by depositing a calcium phosphate layer onto the tooth surface to occlude dentinal tubules and block hydrodynamic flow, which helps reduce sensitivity.

  • How is ORAVIVE TOOTH REVITALIZING PASTE supplied and is it sterile?

    ORAVIVE TOOTH REVITALIZING PASTE is supplied as a toothpaste for over-the-counter consumer use in a home setting. It is non-sterile, as it is not evaluated for sterility and is intended for routine oral hygiene without requiring aseptic conditions.

  • Is ORAVIVE TOOTH REVITALIZING PASTE single-use or reusable?

    ORAVIVE TOOTH REVITALIZING PASTE is a single-use product per application. Each use involves applying the paste to the toothbrush and brushing, after which the product is discarded; it is not intended to be reused or refilled for multiple applications.

  • What regulatory pathway was used for ORAVIVE TOOTH REVITALIZING PASTE?

    ORAVIVE TOOTH REVITALIZING PASTE received FDA 510(k) clearance under K040473, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under product code LBH and regulation number 872.3260.