JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
Summary
Dent4you AG received 510(k) clearance for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST, a ELW device. Cleared on 2025-06-27.
Details
Source
510(k) Clearance
External ID
K250969
Action Date
2025-06-27
Status
Abbreviated
Category
device
Product Code
ELW
Product Description
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST. Product code: ELW.
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. Dent4you AG has received 4 total clearances in our database.
Dent4you AG has 4 FDA actions in our database, including 4 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 Dent4you AG have FDA actions?
Dent4you AG has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250969" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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