FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Spark Clear Aligner System
K Number: K240501
·
Decision Oct 11, 2024
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
6
Review Days
233
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Basic Information
- Device Name
- Spark Clear Aligner System
- K Number
- K240501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ormco Corporation
- Date Received
- February 21, 2024
- Decision Date
- October 11, 2024
- 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 Ormco Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K250487 | SparkTM Clear Aligner System | Feb 20, 2025 | Substantially Equivalent |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | Jan 3, 2025 | Substantially Equivalent |
| K203737 | Spark Clear Aligner System | Mar 22, 2021 | Substantially Equivalent |
| K172845 | Symetri Clear | Jan 31, 2018 | Substantially Equivalent |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Jul 18, 2017 | Substantially Equivalent |