CLEARFIL™ Universal Bond

Basic Information

• Brand Name: CLEARFIL™ Universal Bond
• Primary DI: EKUR003293KA1
• Version / Model: #3293-KA
• Company Name: KURARAY NORITAKE DENTAL INC.
• Labeler DUNS: 697119498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2017-02-17
• Public Version: 5
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 2a0b7b64-b754-4f7b-b0d4-3ba0a62b434d

Device Description

Bottle Value Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	Varnish, Cavity	Dental	872.3260	2
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKUR003293KA1	HIBCC
Unit of Use	EKUR003293KA0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K132450	000