FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Tokuyama Universal Bond II
K Number: K203760
·
Decision May 25, 2021
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
19
Review Days
153
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
- Tokuyama Universal Bond II
- K Number
- K203760
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tokuyama Dental Corporation
- Date Received
- December 23, 2020
- Decision Date
- May 25, 2021
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
Porcelain Etch Gel
FDA 510(k)
FDA Class 2
·Dental
Adhese 2
FDA 510(k)
FDA Class 2
·Dental
Bond-PR Universal Adhesive
FDA 510(k)
FDA Class 2
·Dental
VITA VMLC Primer
FDA 510(k)
FDA Class 2
·Dental
els unibond
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Tokuyama Dental Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K203598 | Omnichroma Flow Bulk | Feb 3, 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 |