EdgeUtopia RRM Dispensing Gun

Basic Information

• Brand Name: EdgeUtopia RRM Dispensing Gun
• Primary DI: 07898078659427
• Version / Model: EdgeUtopia RRM Dispensing Gun - 1 unit
• Catalog Number: 38060
• Company Name: Angelus Industria de Produtos Odontologicos S A
• Labeler DUNS: 906943303
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-20
• Public Version: 1
• Public Version Date: 2025-03-28
• Public Version Status: New
• Public Device Record Key: c8d26656-06f0-4987-8a5d-d3f5c1f5f739

Device Description

System for application of dental materials.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EKI	Carrier, Amalgam, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16196	Dental material cartridge-plunging applicator, single-component	A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898078659427	GS1

Customer Contacts

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