FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Omnichroma Flow Bulk
K Number: K203598
·
Decision Feb 3, 2021
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
19
Review Days
56
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Basic Information
- Device Name
- Omnichroma Flow Bulk
- K Number
- K203598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tokuyama Dental Corporation
- Date Received
- December 9, 2020
- Decision Date
- February 3, 2021
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Tokuyama Dental Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K203760 | Tokuyama Universal Bond II | May 25, 2021 | Substantially Equivalent |
| K193537 | Omnichroma Flow | Aug 19, 2020 | Substantially Equivalent |
| K190940 | Tokuyama Rebase III | Oct 4, 2019 | Substantially Equivalent |
| K180613 | Estelite Universal Flow | Jul 12, 2018 | Substantially Equivalent |
| K173275 | OMNICHROMA | Feb 27, 2018 | Substantially Equivalent |
| K171226 | TOKUYAMA UNIVERSAL BOND | Nov 28, 2017 | Substantially Equivalent |
| K170549 | TOKUYAMA CUREGRACE | Jul 5, 2017 | Substantially Equivalent |
| K161353 | ESTELITE BULK FILL Flow | Apr 3, 2017 | Substantially Equivalent |
| K150727 | ESTECEM | Jun 17, 2015 | Substantially Equivalent |
| K112445 | SOFRELINER TOUGH S | Oct 28, 2011 | Substantially Equivalent |