FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Carriere Motion Clear Class II
K Number: K160720
·
Decision Nov 28, 2016
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
8
Review Days
257
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Basic Information
- Device Name
- Carriere Motion Clear Class II
- K Number
- K160720
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Organizers, Inc.
- Date Received
- March 16, 2016
- Decision Date
- November 28, 2016
- Product Code
- DYW
- 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 |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | FDA class 2 | Dental |
Similar 510(k) Clearances
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CompleClear Plastic Orthodontic Bracket and Wire Appliance
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Other Clearances by Ortho Organizers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Nov 27, 2025 | Substantially Equivalent |
| K173440 | Carriere SLX 3D Clear | Mar 8, 2018 | Substantially Equivalent |
| K110335 | CERAMIC BRACKETS | May 19, 2011 | Substantially Equivalent |
| K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | Jul 31, 2006 | Substantially Equivalent |
| K923218 | NITANIUM PALATAL EXPANDER | Sep 13, 1993 | Substantially Equivalent |
| K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | Sep 1, 1993 | Substantially Equivalent |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | Jul 8, 1993 | Substantially Equivalent |