Skip to content

Dent-Dr. Vacu-Frame

by Dent-Dr. 510(k)

Active United States

510(k) K851045

Overview

A comprehensive directory of medical devices, featuring the DENT-DR. VACU-FRAME device with a history dating back to 1985 and regulatory clearance through the FDA.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851045 Date22 Apr 1985ClearedStatusActive

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  • Withdrawn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
EIE
Device Class
Class I
Regulation
21 CFR Part 872.6300
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent