Injectable Root Canal Bioceramic Sealer
Summary
Beijing C-Root Dental Medical Devices Co., Ltd. received 510(k) clearance for Injectable Root Canal Bioceramic Sealer, a KIF device. Cleared on 2021-12-08.
Details
Source
510(k) Clearance
External ID
K212983
Action Date
2021-12-08
Status
Traditional
Category
device
Product Code
KIF
Product Description
Injectable Root Canal Bioceramic Sealer. 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. Beijing C-Root Dental Medical Devices Co., Ltd. has received 2 total clearances in our database.
Beijing C-Root Dental Medical Devices 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 Beijing C-Root Dental Medical Devices Co., Ltd. have FDA actions?
Beijing C-Root Dental Medical Devices 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 "K212983" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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