SplashMax®

Basic Information

• Brand Name: SplashMax®
• Primary DI: D8130308971011
• Version / Model: 030897101
• Catalog Number: 030897101
• Company Name: DEN-MAT HOLDINGS, LLC
• Labeler DUNS: 809857704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 11
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 1
• Public Version Date: 2022-09-30
• Public Version Status: New
• Public Device Record Key: 4c81902d-9c1f-4d47-ab55-62712d04ab76

Device Description

SPLASH MX JMB YL TIP&RNG 11pc

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D8130308971010	HIBCC
Primary	D8130308971011	HIBCC

Customer Contacts

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