Dolphin Imaging 12.0
Summary
Patterson Dental Supply, Inc. received 510(k) clearance for Dolphin Imaging 12.0, a LLZ device. Cleared on 2022-08-08.
Details
Source
510(k) Clearance
External ID
K222072
Action Date
2022-08-08
Status
Special
Category
device
Product Code
LLZ
Product Description
Dolphin Imaging 12.0. Product code: LLZ.
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. Patterson Dental Supply, Inc. has received 2 total clearances in our database.
Patterson Dental Supply, Inc. 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 Patterson Dental Supply, Inc. have FDA actions?
Patterson Dental Supply, Inc. 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 "K222072" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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