Anew Surgical and Prosthetic Instrumentation Kit

Basic Information

• Brand Name: Anew Surgical and Prosthetic Instrumentation Kit
• Primary DI: 07350081494858
• Version / Model: SK-3
• Catalog Number: SK-3
• Company Name: Dentatus AB
• Labeler DUNS: 355803412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 75e51766-50a9-44ec-8ab0-5d429607f6aa

Device Description

ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 2 2 - 1.4 Center Point Pilot Drills (1 Short & 1 Long) (=1.8 Impl. Diam.) - Drill System 2 2 - CePo Drills for 2.2 and 2.4 Implants 1 - Manual Adaptor for R/A Driver 1 - Anew Chisel-End Screwcap Driver 1 - R/A Hpc Driver 1 - Trephine Hollow Drill 1 - Sterilizable Instrumentation Kit Box 1 - Instruction for use 1 - X-ray template 5 - Moisture Absorbing Papers

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44881	Dental implant suprastructure kit	A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350081494858	GS1

Customer Contacts

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