CEKA & PRECI-LINE ATTACHMENTS

Basic Information

• Brand Name: CEKA & PRECI-LINE ATTACHMENTS
• Primary DI: 14260576941128
• Version / Model: 1705
• Catalog Number: 1705
• Company Name: Alphadent NV
• Labeler DUNS: 283174985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-03-30
• Public Version: 1
• Public Version Date: 2021-04-07
• Public Version Status: New
• Public Device Record Key: 2f2eb631-2c60-4eff-a1b2-2746638e563a

Device Description

Preci-Horix Insertion Tool

Device Characteristics

• Single Use: No
• 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: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJB	HANDLE, INSTRUMENT, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16669	Steel dental bur, reusable	A rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.	No	Active
16670	Diamond dental bur, reusable	A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04260576941121	GS1
Primary	14260576941128	GS1

Customer Contacts

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