KLOCKNER

Basic Information

• Brand Name: KLOCKNER
• Primary DI: 08435451604842
• Version / Model: 18 05 13
• Catalog Number: 18 05 13
• Company Name: SOADCO, S.L.
• Labeler DUNS: 464517122
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-14
• Public Version: 1
• Public Version Date: 2022-07-22
• Public Version Status: New
• Public Device Record Key: d9fab36e-985e-41a1-8af3-6fb032e8ee21

Device Description

VEGA PERMANENT ABUTMENT PROTECTIVE CAP [4.0MM]

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
NHA	Abutment, implant, dental, endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42350	Intramucosal dental implant	A sterile device made of alloplastic materials intended to be surgically implanted into the soft-tissue lining of the oral cavity (intramucosal insert) to provide support and a means of retention for a dental prosthesis (typically removable dentures).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08435451604842	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153098	000