Root canal repair materials (nRoot BP)
Summary
Enpuno Biotechnology Co., Ltd. received 510(k) clearance for Root canal repair materials (nRoot BP), a KIF device. Cleared on 2025-09-25.
Details
Source
510(k) Clearance
External ID
K251465
Action Date
2025-09-25
Status
Traditional
Category
device
Product Code
KIF
Product Description
Root canal repair materials (nRoot BP). Product code: KIF.
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. Enpuno Biotechnology Co., Ltd. has received 2 total clearances in our database.
Enpuno Biotechnology Co., Ltd. has 2 FDA actions in our database, including 2 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 Enpuno Biotechnology Co., Ltd. have FDA actions?
Enpuno Biotechnology Co., Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251465" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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