FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
KATANA Cleaner, KATANA Cleaner (Trial)
K Number: K191133
·
Decision Oct 8, 2019
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
2
Applicant Total
32
Review Days
162
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Basic Information
- Device Name
- KATANA Cleaner, KATANA Cleaner (Trial)
- K Number
- K191133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kuraray Noritake Dental, Inc.
- Date Received
- April 29, 2019
- Decision Date
- October 8, 2019
- Product Code
- PME
- 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 |
|---|---|---|---|
| PME | External Cleaning Solution | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PME), ordered by most recent decision date.
View allOther Clearances by Kuraray Noritake Dental, Inc.
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| K220369 | Esthetic Colorant | Sep 23, 2022 | Substantially Equivalent |
| K213147 | CERABIEN MiLai | Mar 28, 2022 | Substantially Equivalent |
| K210504 | PANAVIA Veneer LC | Jun 11, 2021 | Substantially Equivalent |
| K193060 | Noritake Super Porcelain EX-3 | Jan 30, 2020 | Substantially Equivalent |
| K191980 | CLEARFIL MAJESTY ES Flow | Nov 18, 2019 | Substantially Equivalent |
| K190436 | KATANA Zirconia Block | May 23, 2019 | Substantially Equivalent |
| K182430 | CLEARFIL MAJESTY IC | May 3, 2019 | Substantially Equivalent |