Bio-H Type lV Yellow Crown & Bridge Alloy

Basic Information

• Brand Name: Bio-H Type lV Yellow Crown & Bridge Alloy
• Primary DI: 00841549100239
• Version / Model: 1127006
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-16
• Public Version: 5
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: 34a51b3e-4eac-4dee-b52d-e743ad002ff4

Device Description

High Noble. Type IV crown and bridge alloy. Bio-H is extra hard. When heat treated its Vickers value is 290. It also has good yield strength and can be used for bridges and removable partial denture frameworks.

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: 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
35858	Dental casting noble alloy	A material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. 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	00841549100239	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K962326	000