FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K Number: K180718
·
Decision Oct 30, 2018
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
4
Review Days
225
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
- K Number
- K180718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tomy, Inc.
- Date Received
- March 19, 2018
- Decision Date
- October 30, 2018
- 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
Other 510(k) clearances with the same product code (DYW), ordered by most recent decision date.
Carriere® Motion Pro® Clear Bite Corrector
FDA 510(k)
FDA Class 2
·Dental
Composite Orthodontic Brackets and Buttons
FDA 510(k)
FDA Class 2
·Dental
Braces on Demand Bracket
FDA 510(k)
FDA Class 2
·Dental
Blue Sky Bio Computerized Orthodontic Bracket System
FDA 510(k)
FDA Class 2
·Dental
Carriere Motion Clear Class II
FDA 510(k)
FDA Class 2
·Dental
CompleClear Plastic Orthodontic Bracket and Wire Appliance
FDA 510(k)
FDA Class 2
·Dental