FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TP Orthodontics Clear Aligner System
K Number: K193385
·
Decision Nov 12, 2020
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
5
Review Days
342
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Basic Information
- Device Name
- TP Orthodontics Clear Aligner System
- K Number
- K193385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tp Orthodontics, Inc.
- Date Received
- December 6, 2019
- Decision Date
- November 12, 2020
- 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 Tp Orthodontics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Oct 14, 2022 | Substantially Equivalent |
| K111234 | CLICK-IT | May 13, 2011 | Substantially Equivalent |
| K952643 | RIGHT-ON ADHESIVE BOUDING SYSTEM | Jul 11, 1995 | Substantially Equivalent |
| K950992 | CERAMAFLEX BRACKET SYSTEM | May 3, 1995 | Substantially Equivalent |