Visio-Dispers
by Espe GmbH (Us) 510(k)
Active
510(k) K790823
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790823 | Date22 Oct 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Visio-Dispers is a dental device, classified as a material, tooth shade, resin. It is a class 2 device, substantially equivalent to other devices in the same classification.
The device is supplied with FDA 510(k) clearance, with the product code EBF and regulation number 872.3690. It is used in the dental medical specialty, with a traditional clearance type, and is classified as substantially equivalent, with a decision date of 1979-10-22.
Other devices from Espe GmbH (Us)
Questions
AI-generated answers, 24 Sep 2026
What is the Visio-Dispers used for?
The Visio-Dispers is used in the dental medical specialty as a tooth shade resin material.
Is the Visio-Dispers supplied sterile?
The device data does not specify if the Visio-Dispers is supplied sterile, it is recommended to consult the manufacturer's instructions.
What is the regulatory classification of the Visio-Dispers?
The Visio-Dispers is classified as a class 2 device, substantially equivalent to other devices in the same classification, with FDA 510(k) clearance.