KLOCKNER

Basic Information

• Brand Name: KLOCKNER
• Primary DI: 08435451602558
• Version / Model: 10 14 05
• Catalog Number: 10 14 05
• Company Name: SOADCO, S.L.
• Labeler DUNS: 464517122
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 4325469b-43e4-4b87-91e7-938955524817

Device Description

EC BALL ATTACHMENT

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
38590	Overdenture	A custom-made, removable, artificial replacement for some or all teeth in the lower or upper jaw (mandible or maxilla) that is retained in the mouth with precision dental attachments. The attachments can be placed in retained tooth roots or dental implants.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08435451602558	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122988	000