FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Byte Aligner System
K Number: K230199
·
Decision Oct 18, 2023
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
21
Review Days
266
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Basic Information
- Device Name
- Byte Aligner System
- K Number
- K230199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Sirona, Inc.
- Date Received
- January 25, 2023
- Decision Date
- October 18, 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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