Lava™

Basic Information

• Brand Name: Lava™
• Primary DI: 30605861041950
• Version / Model: 3112A3-HT
• Catalog Number: 3112A3-HT
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2020-08-31
• Public Version Status: Update
• Public Device Record Key: 934fdbd7-1064-4bd4-a3d2-dd8126e20707
• Distribution End Date: 2020-08-31

Device Description

3M™ ESPE™ Lava™ Ultimate Restorative for E4D™ 12, shade A3-HT, 3112A3-HT

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	50605861041954	GS1	BOX	10	Not in Commercial Distribution	2020-08-31
Primary	30605861041950	GS1
Unit of Use	00605861041959	GS1

Customer Contacts

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