Temporary Crown Matrix Buttons

Basic Information

• Brand Name: Temporary Crown Matrix Buttons
• Primary DI: 00859787002055
• Version / Model: 100
• Company Name: ADVANTAGE DENTAL PRODUCTS INC
• Labeler DUNS: 607859147
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 72
• Record Status: Published
• Publish Date: 2016-10-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4a83d6ee-82b0-4d1e-b5b8-900525ca3434

Device Description

Thermoplastic disk used to make custom temporary crown and bridge restorations

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: No
• 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
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58288	Dental appliance fabrication material, thermoplastic	A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10859787002052	GS1	Box	24	In Commercial Distribution
Primary	00859787002055	GS1
Unit of Use	00859787002222	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry conditions. Do not store with acids or alkalis
• Type: Storage Environment Temperature
• Temperature Range: – 125 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: – 125 Degrees Fahrenheit