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Salivart Artificial Saliva

by Westport Pharmaceuticals, Inc.

PMA P790016

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P790016↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP790016 Date19 Sep 1979ApprovedStatusActive

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  • Withdrawn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 PMA Active

Specification

PMA

Full name
Salivart
Generic Name
Saliva, artificial
PMA Number
FDA Product Code
LFD
Device Class
U
Advisory Committee
Dental
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

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

Salivart Artificial Saliva is an artificial saliva substitute designed to replicate the natural properties of human saliva. It is classified as a dental device and serves to maintain oral moisture, reduce dryness, and support oral comfort in patients with xerostomia or those undergoing radiation therapy.

This device is supplied as a sterile, single-use solution intended for intraoral application. It is regulated under an FDA Premarket Approval (PMA) and distributed in various sizes and formulations, as indicated by its registration numbers. Storage and handling follow standard sterile product protocols to ensure efficacy and safety.

Questions

AI-generated answers, 18 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 Salivart primarily used for in clinical practice?

    Salivart Artificial Saliva is designed to replicate the natural properties of human saliva, helping to maintain oral moisture and reduce dryness in patients with xerostomia (dry mouth) or those undergoing radiation therapy. It supports oral comfort by providing lubrication and hydration to the oral cavity.

  • How is Salivart supplied, and is it meant for single-use or reuse?

    Salivart is supplied as a sterile, single-use solution intended specifically for intraoral application. This ensures safety and efficacy, as reuse could compromise sterility and potentially introduce contamination.

  • What storage and handling precautions should be taken with Salivart?

    Since Salivart is a sterile product, it must be stored and handled according to standard sterile product protocols. This includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.

  • Are there different sizes or formulations available for Salivart?

    Yes, Salivart is available in multiple sizes and formulations, as indicated by its registration numbers (e.g., 3001237145, 3014468707, etc.). These variations likely cater to different patient needs or clinical scenarios, though exact differences would require referencing the specific product labeling.

  • How was Salivart approved by the FDA, and what does this mean for its regulatory status?

    Salivart was approved through the FDA’s Premarket Approval (PMA) process, as indicated by its PMA number (P790016). This means the device underwent rigorous review to ensure its safety and effectiveness for its intended use as an artificial saliva substitute, providing assurance of its regulatory compliance.