Health-Tec Temporary C&B Material 4:1

Basic Information

• Brand Name: Health-Tec Temporary C&B Material 4:1
• Primary DI: D773110100041
• Version / Model: 110-10004
• Catalog Number: 110-10004
• Company Name: Dental Health Products Inc
• Labeler DUNS: 623191194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-24
• Public Version: 3
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: f14d3670-054c-4f0c-98f7-fdc5d0ece0fa

Device Description

Health-Tec Temporary C&B Material 4:1, Shade B1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
EFH	Paper, Articulation	Dental	872.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D773110100041	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 58 – 77 Degrees Fahrenheit