SFI-Bar

Basic Information

• Brand Name: SFI-Bar
• Primary DI: 07640166510314
• Version / Model: 07000108
• Catalog Number: 07000108
• Company Name: Cendres+Métaux SA
• Labeler DUNS: 487506230
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-14
• Public Version: 2
• Public Version Date: 2021-04-28
• Public Version Status: Update
• Public Device Record Key: baf40595-bebc-47bc-b773-7ca448c4ac31
• Distribution End Date: 2020-10-27

Device Description

0700 0108 Instrument set Instrument set Including: 0700 0114 Screwdriver 0700 0115 Hex key 070 221 Thomas spanner key 0700 0107 Transfer jig L26 0700 0106 Tube bar gauge 0700 0100 Gauge aid 0700 0036 Insert positioner 0700 0111 ImplantPlanner 070 347 Tweezers 070 198 Activator set 070 201 Desactivator macro Sample Premium Disc No. 1, 3 pieces

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38577	Bar dental precision attachment	A small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640166510314	GS1

Customer Contacts

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