STELLAR iJig

Basic Information

• Brand Name: STELLAR iJig
• Primary DI: D8375011400
• Version / Model: Tooth White Resin - 1ea 5.85 gm Syr
• Catalog Number: 50-1140
• Company Name: Taub Products
• Labeler DUNS: 067488114
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-19
• Public Version: 2
• Public Version Date: 2019-09-06
• Public Version Status: Update
• Public Device Record Key: 43ba576e-ed99-4640-bd11-bc99c7863303

Device Description

STELLAR iJig / Tooth White Resin is a dual cure acrylic that light cures in 20 seconds and self cures in 120 seconds. Used for All-on-X pick-up and conversions, build up esthetic PMMA Tooth structure, Implant Verification Jigs, Indexes. Create Pickup Impression Copings. Position misaligning implant components during seating. Connect or fix single implant parts for soldering and welding.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKO	Denture Preformed (Partially Prefabricated Denture)	Dental	872.3600	2
EBH	Material, Impression Tray, Resin	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63591	Dental acrylic resin	A non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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	D8375011400	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	5.85	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Extremely light sensitive. Keep original cap on syringe directly before and after use. Keep away from heat. Refrigerate. See SDS.