SciPharm Sci-Span Crown and Bridge Material & Restorative

Basic Information

• Brand Name: SciPharm Sci-Span Crown and Bridge Material & Restorative
• Primary DI: D801SP58014N1
• Version / Model: SP 58-014 N
• Catalog Number: 58-014
• Company Name: SCIENTIFIC PHARMACEUTICALS, INC.
• Labeler DUNS: 096010525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 4
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: f3974d80-a984-456c-925b-cab1d927cde8

Device Description

Sci-Span - A Crown & Bridge Material Designed for Fast In-Situ Fabrication of Dental Prosthesis. Dual Barrel Syringe. C2 Shade. Non-Boxed.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D801SP58014N1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041886	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 73 Degrees Fahrenheit