DESS Dental Smart Solutions
Summary
Terrats Medical SL received 510(k) clearance for DESS Dental Smart Solutions, a NHA device. Cleared on 2021-08-04.
Details
Source
510(k) Clearance
External ID
K203464
Action Date
2021-08-04
Status
Traditional
Category
device
Product Code
NHA
Product Description
DESS Dental Smart Solutions. Product code: NHA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Terrats Medical SL has received 17 total clearances in our database.
Terrats Medical SL has 17 FDA actions in our database, including 17 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Terrats Medical SL have FDA actions?
Terrats Medical SL has 17 FDA actions in our database, including 0 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K203464" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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