CEPHX- Cephalometric Analysis Software
Summary
Orca Dental AI , Ltd. received 510(k) clearance for CEPHX- Cephalometric Analysis Software, a LLZ device. Cleared on 2024-01-31.
Details
Source
510(k) Clearance
External ID
K231396
Action Date
2024-01-31
Status
Traditional
Category
device
Product Code
LLZ
Product Description
CEPHX- Cephalometric Analysis Software. Product code: LLZ.
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. Orca Dental AI , Ltd. has received 2 total clearances in our database.
Orca Dental AI , 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 Orca Dental AI , Ltd. have FDA actions?
Orca Dental AI , 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 "K231396" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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