Rocatec™ Soft

Basic Information

• Brand Name: Rocatec™ Soft
• Primary DI: 04035077004794
• Version / Model: 68377
• Catalog Number: 68377
• Company Name: 3M Deutschland GmbH
• Labeler DUNS: 315731711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-08
• Public Version: 4
• Public Version Date: 2018-09-21
• Public Version Status: Update
• Public Device Record Key: c61f7ec5-75e1-4407-8efa-e2f6a7ddc56e

Device Description

3M™ ESPE™ Rocatec™ Soft for use with Lava™ DVS Digital Veneering System, 3kg, 68377

Device Characteristics

• Single Use: No
• 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
EJH	ALLOY, METAL, BASE	Dental	872.3710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62477	Dental composite resin kit	A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. 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	04035077004794	GS1
Direct Marking	04035077024136	GS1

Customer Contacts

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