CLEARFIL Universal Bond Quick 2
Summary
Kuraray Noritake Dental, Inc. received 510(k) clearance for CLEARFIL Universal Bond Quick 2, a KLE device. Cleared on 2023-12-13.
Details
Source
510(k) Clearance
External ID
K231039
Action Date
2023-12-13
Status
Traditional
Category
device
Product Code
KLE
Product Description
CLEARFIL Universal Bond Quick 2. Product code: KLE.
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. Kuraray Noritake Dental, Inc. has received 5 total clearances in our database.
Kuraray Noritake Dental, Inc. has 5 FDA actions in our database, including 5 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 Kuraray Noritake Dental, Inc. have FDA actions?
Kuraray Noritake Dental, Inc. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231039" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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