Ceramco®

Basic Information

• Brand Name: Ceramco®
• Primary DI: D00139515140
• Version / Model: Bio-Pre Solder N/S
• Catalog Number: 3951514
• Company Name: Dentsply International Inc.
• Labeler DUNS: 606173334
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 3
• Public Version Date: 2022-05-06
• Public Version Status: Update
• Public Device Record Key: 334b066d-a1c9-405a-8ff2-1740ddb2f193
• Distribution End Date: 2022-04-13

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJT	ALLOY, GOLD-BASED NOBLE METAL	Dental	872.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38779	Dental soldering alloy	A mixture of metals in the form of a thin rod used to solder cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the soldering metal melts around the joint to create the fusion. The soldering process operates at lower termperatures than brazing. 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	D00139515140	HIBCC

Customer Contacts

• Phone: [phone] ext. 54660
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	2	Gram