Sebond Bondopaker C3

Basic Information

• Brand Name: Sebond Bondopaker C3
• Primary DI: ESDG6440981
• Version / Model: 644098
• Company Name: Schütz Dental GmbH
• Labeler DUNS: 315830349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2c62d9d1-cb17-43bf-aef2-21bb1748c0bd

Device Description

Dentine colored bonding opaque, C3, 2 g

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: Yes
• 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
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37543	Dental bridge, metal-polymer	A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy with a tooth-coloured polymer material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ESDG6440981	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius