ADAPTATER RISKONTROL DCI

Basic Information

• Brand Name: ADAPTATER RISKONTROL DCI
• Primary DI: 03760243000089
• Version / Model: RISKONTROL
• Catalog Number: 200152
• Company Name: ACTEON MANUFACTURING
• Labeler DUNS: 283473691
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-21
• Public Version: 3
• Public Version Date: 2025-07-31
• Public Version Status: Update
• Public Device Record Key: c4d4251b-6d9f-4346-a112-3883e7b1b063

Device Description

The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECB	Unit, Syringe, Air And/Or Water	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45131	Dental delivery system irrigation handpiece	A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760243000089	GS1

Customer Contacts

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