Paradigm™

Basic Information

• Brand Name: Paradigm™
• Primary DI: 30605861036895
• Version / Model: 2714B3-S
• Catalog Number: 2714B3-S
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8dc5f946-41f4-4e82-b14e-f6639a922135

Device Description

3M™ ESPE™ Paradigm™ MZ100 Blocks for CEREC™ System Refill, Shade B3, Size 14, 5 Blocks/Pack, 2714B3-S

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: 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
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38649	Resin dental inlay	A custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50605861036899	GS1	BOX	10	In Commercial Distribution
Primary	30605861036895	GS1
Unit of Use	00605861036894	GS1

Customer Contacts

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