DESS Dental Smart Solutions
by Terrats Medical SL 510(k)
Active
510(k) K191986
Overview
DESS Dental Smart Solutions is a dental device. It is substantially equivalent to a predicate device and was cleared through the traditional 510(k) pathway.
The device is manufactured by Terrats Medical SL in Barberá Del Vallés, Spain. It has FDA 510(k) authorization under K191986 and product code NHA. The advisory committee classification is Dental.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191986 | Date10 Nov 2019 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Terrats Medical, S.L.
Questions
What is the DESS Dental Smart Solutions device used for?
The DESS Dental Smart Solutions is a dental device, as indicated by its product code NHA and advisory committee classification Dental, intended for dental applications based on its substantial equivalence to a predicate device.
How was the DESS Dental Smart Solutions device cleared for market?
The device was cleared through the FDA's traditional 510(k) pathway, as it was determined to be substantially equivalent to a predicate device, with authorization granted under K191986 on November 10, 2019.
Who manufactures the DESS Dental Smart Solutions and where is it made?
The DESS Dental Smart Solutions is manufactured by Terrats Medical SL, located at Carrer Mogoda 75-99, Barberá Del Vallés, Spain, with postal code 08210 and country code ES.