Identity
- Trade Name
- KATANA Cleaner FDA UDI
- Generic Name
- Dental restoration fixation cleaning solution FDA UDI
- Model / Reference
- #3970-KA FDA UDI
Identifiers
- Primary DI / UDI-DI
- EKUR003970KA1 FDA UDI
- 510(k) Number
- K191133 FDA UDI
- FDA Product Code
- LBH FDA UDIPME FDA UDI
- GMDN Term
- Dental restoration fixation cleaning solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental restoration fixation cleaning solution
KATANA Cleaner by Kuraray Noritake Dental Inc. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental restoration fixation cleaning solution.
- ZirClean — BISCO INC. · Class II
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- ZrC Syringe Kit — Vista Dental · Class II
- UniClean — Vista Dental · Class II
- ZrC Bottle — Vista Dental · Class II
- KATANA Cleaner — KURARAY NORITAKE DENTAL INC. · Class II
Cleared under the same submission
K191133 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc.
Sources (2)
- FDA UDI 703604d8-b105-4c14-b002-0df570ea5a7b 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026