ASTRA TECH Implant System®

Basic Information

• Brand Name: ASTRA TECH Implant System®
• Primary DI: 07392532003219
• Version / Model: 22874
• Catalog Number: 22874
• Company Name: Dentsply Implants Manufacturing GmbH
• Labeler DUNS: 344038836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 3
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: 9fbbc24b-da0f-4ea3-a082-c305c9c6e101
• Distribution End Date: 2023-01-13

Device Description

Profile BiAbutment 4.5/5.0 - Ø 7.0 mm

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: 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
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
Primary	07392532003219	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage in the original packaging, in a dry place, at normal room temperature.