Anew Implantat System

Basic Information

• Brand Name: Anew Implantat System
• Primary DI: 07350081494797
• Version / Model: ST-28L
• Company Name: Dentatus AB
• Labeler DUNS: 355803412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9556bab9-b646-43df-a980-821ce0ae19ff

Device Description

Dentatus Anew Implant, blister pack including 1 pc

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZE	Implant, Endosseous, Root-Form	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42354	Transgingival implant	A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07350081495350	GS1	Implant pack	1	In Commercial Distribution
Primary	07350081494797	GS1
Package	07350081495398	GS1	Implant pack	2	In Commercial Distribution

Customer Contacts

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