Dentis s-Clean Regular Abutment
Summary
Dentis Co., Ltd. received 510(k) clearance for Dentis s-Clean Regular Abutment, a NHA device. Cleared on 2023-08-04.
Details
Source
510(k) Clearance
External ID
K230126
Action Date
2023-08-04
Status
Traditional
Category
device
Product Code
NHA
Product Description
Dentis s-Clean Regular Abutment. 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. Dentis Co., Ltd. has received 18 total clearances in our database.
Dentis Co., Ltd. has 18 FDA actions in our database, including 18 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 Dentis Co., Ltd. have FDA actions?
Dentis Co., Ltd. has 18 FDA actions in our database, including 0 recalls and 18 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230126" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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