3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Summary
3M Company, Unitek Orthodontic Products received 510(k) clearance for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex), a NXC device. Cleared on 2023-05-22.
Details
Source
510(k) Clearance
External ID
K231464
Action Date
2023-05-22
Status
Traditional
Category
device
Product Code
NXC
Product Description
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex). Product code: NXC.
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. 3M Company, Unitek Orthodontic Products has received 2 total clearances in our database.
3M Company, Unitek Orthodontic Products 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 3M Company, Unitek Orthodontic Products have FDA actions?
3M Company, Unitek Orthodontic Products 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 "K231464" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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