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Dental Mouth Prop

by Trident Dental, Inc. 510(k)

Active United States

510(k) K802696

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802696 Date12 Nov 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JXL
Device Class
Class II
Regulation
21 CFR Part 882.5070
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Dental Mouth Prop is a bite block device designed to maintain an open mouth position during dental procedures. It provides gentle support to keep the mouth comfortably open across a range of patient ages and needs.

This device is manufactured from soft, autoclavable silicone to facilitate sterilization. It is supplied in small, medium, and large sizes for versatile clinical use. The device is authorized under FDA 510K clearance.

Other devices from Trident Dental, Inc.

  • Royal

    Class II

  • Windsor

    Class II

Questions

AI-generated answers, 6 Oct 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 Dental Mouth Prop?

    The Dental Mouth Prop is designed to maintain an open mouth position for patients during dental procedures, providing gentle support to keep the mouth comfortably open.

  • Is the Dental Mouth Prop reusable?

    This device is manufactured from soft, autoclavable silicone. This material choice allows the device to be sterilized between uses to maintain clinical hygiene standards.

  • What sizes are available for this bite block?

    The device is supplied in three distinct sizes—small, medium, and large—to ensure versatile clinical use across a range of patient ages and anatomical needs.

  • What is the regulatory status of this device?

    The Trident Dental Mouth Prop is authorized under FDA 510K clearance, which signifies that the device has been determined to be substantially equivalent to legally marketed predicate devices.