FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ormco Spark Aligner System
K Number: K182826
·
Decision Oct 11, 2018
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
15
Review Days
6
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Basic Information
- Device Name
- Ormco Spark Aligner System
- K Number
- K182826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sybron Dental Specialties
- Date Received
- October 5, 2018
- Decision Date
- October 11, 2018
- Product Code
- NXC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
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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