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Salitron System

by Biosonics, Inc.

PMA P860067

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P860067↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP860067 Date17 May 1988ApprovedStatusActive

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  • Withdrawn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 PMA Active

Specification

PMA

Generic Name
Stimulator, salivary system
PMA Number
FDA Product Code
LTF
Device Class
Class II
Regulation
21 CFR Part 872.5560
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.

The Salitron System is a Stimulator, Salivary System (Device Class II), designed to electrically stimulate salivary glands to promote saliva production. This device is intended for use in dental applications to aid in patient comfort during procedures by reducing dry mouth, a common issue in oral healthcare settings.

The system is supplied as a reusable medical device and is regulated under FDA Premarket Approval (PMA P860067). It is classified under the dental specialty and adheres to FDA standards for Class II devices, specifically under regulation number 872.5560. No specific sterility or MRI safety information is provided in the data, but it is intended for use in clinical dental environments.

Other devices from Biosonics, Inc.

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 the primary purpose of the Salitron System in dental procedures?

    The Salitron System is designed to electrically stimulate salivary glands to increase saliva production. This helps alleviate dry mouth, a common issue during dental treatments, thereby enhancing patient comfort and improving the overall experience for both the patient and clinician.

  • Is the Salitron System intended for single-use or can it be reused?

    The Salitron System is explicitly described as a reusable medical device. Since it is classified as a Class II device under FDA regulations, it is engineered for repeated use in clinical dental settings, provided proper maintenance and cleaning protocols are followed.

  • How is the Salitron System regulated by the FDA, and what does that mean for its use?

    The Salitron System holds an FDA Premarket Approval (PMA) under number P860067, which means it has undergone rigorous review to ensure safety and effectiveness. This approval allows it to be legally marketed and used in dental settings for its intended purpose of stimulating saliva production, adhering to FDA standards for Class II devices.

  • Are there specific storage instructions or considerations for the Salitron System?

    The provided data does not explicitly detail storage instructions, but as a reusable device intended for clinical dental use, it should be stored in a clean, dry environment to prevent contamination or damage. Since it is not labeled as sterile or MRI-safe, it should be handled accordingly in those contexts.