FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K Number: K232233
·
Decision Sep 26, 2023
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
11
Review Days
61
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Basic Information
- Device Name
- Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
- K Number
- K232233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Align Technology, Inc.
- Date Received
- July 27, 2023
- Decision Date
- September 26, 2023
- Product Code
- NXC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NXC | Aligner, Sequential | FDA class 2 | Dental |
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Other Clearances by Align Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252931 | Invisalign® Palatal Expander System | Oct 23, 2025 | Substantially Equivalent |
| K252870 | Invisalign Specifix Attachment System | Oct 9, 2025 | Substantially Equivalent |
| K252380 | Invisalign System | Aug 29, 2025 | Substantially Equivalent |
| K241412 | Invisalign System | Jun 18, 2024 | Substantially Equivalent |
| K232887 | Invisalign Palatal Expander System | Dec 15, 2023 | Substantially Equivalent |
| K222894 | Invisalign System, Pre-Formed Attachment System | Dec 22, 2022 | Substantially Equivalent |
| K220287 | Invisalign System | Apr 7, 2022 | Substantially Equivalent |
| K193659 | iTero Element 5D | Mar 20, 2020 | Substantially Equivalent |
| K181739 | Invisalign System with Mandibular Advancement Feature | Oct 26, 2018 | Substantially Equivalent |
| K143630 | Invisalign System | Nov 18, 2015 | Substantially Equivalent |