MegaGen Zygoma Dental Implant System
Summary
Megagen Implant Co., Ltd. received 510(k) clearance for MegaGen Zygoma Dental Implant System, a DZE device. Cleared on 2026-06-18.
Details
Source
510(k) Clearance
External ID
K251232
Action Date
2026-06-18
Status
Traditional
Category
device
Product Code
DZE
Product Description
MegaGen Zygoma Dental 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 413 device clearances issued this month. Megagen Implant Co., Ltd. has received 14 total clearances in our database.
Megagen Implant Co., Ltd. has 14 FDA actions in our database, including 14 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 Megagen Implant Co., Ltd. have FDA actions?
Megagen Implant Co., Ltd. has 14 FDA actions in our database, including 0 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251232" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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