Identity
- Trade Name
- CLEARFIL Universal Bond Quick FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Bonding Agent Kit FDA UDI
- Model / Reference
- #3569-AL FDA UDI
- Description
- Bonding Agent Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- EKUR003569AL1 FDA UDI
- 510(k) Number
- K161042 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Dentine bonding agent/set
CLEARFIL Universal Bond Quick by Kuraray Noritake Dental Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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Cleared under the same submission
K161042 also covers:
- CLEARFIL Universal Bond Quick — KURARAY NORITAKE DENTAL INC.
- CLEARFIL Universal Bond Quick — KURARAY NORITAKE DENTAL INC.
- CLEARFIL Universal Bond Quick — KURARAY NORITAKE DENTAL INC.
- CLEARFIL Universal Bond Quick — KURARAY NORITAKE DENTAL INC.
- CLEARFIL Universal Bond Quick — KURARAY NORITAKE DENTAL INC.
- CLEARFIL Universal Bond Quick — KURARAY NORITAKE DENTAL INC.
- CLEARFIL Universal Bond Quick — KURARAY NORITAKE DENTAL INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc.
Sources (1)
- FDA UDI 5cdae31c-edb1-45f1-be19-2ad71c5122cd 34 fields · synced May 31, 2026