3M ClarityAligners with Quick Attachments— 510(k) K233257
Substantially Equivalent3M Company, Unitek Orthodontic Products
FDA 510(k) clearance K233257 for 3M ClarityAligners with Quick Attachments, Substantially Equivalent on 2023-09-29. Applicant: 3M Company, Unitek Orthodontic Products. Device class: 2.
Clearance details
- Applicant
- 3M Company, Unitek Orthodontic Products
- Product code
- Code NXC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Paul, MN, US
Recent devices under product code NXC
view allMore clearances from 3M Company, Unitek Orthodontic Products
view allAdverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K233257
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233257.
Data sourced from openFDA. This site is unofficial and independent of the FDA.