SD TL Implant System
Summary
Arum Dentistry Co., Ltd. received 510(k) clearance for SD TL Implant System, a DZE device. Cleared on 2025-07-23.
Details
Source
510(k) Clearance
External ID
K250280
Action Date
2025-07-23
Status
Traditional
Category
device
Product Code
DZE
Product Description
SD TL Implant System. Product code: DZE.
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. Arum Dentistry Co., Ltd. has received 15 total clearances in our database.
Arum Dentistry Co., Ltd. has 15 FDA actions in our database, including 15 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 Arum Dentistry Co., Ltd. have FDA actions?
Arum Dentistry Co., Ltd. has 15 FDA actions in our database, including 0 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250280" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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