Bollard Skeletal Anchor

Basic Information

• Brand Name: Bollard Skeletal Anchor
• Primary DI: 05430000515115
• Version / Model: BH-UL-19-Y
• Company Name: Tita-Link BVBA
• Labeler DUNS: 371014109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 72218a7c-95af-4f3e-a789-1039d54a62be

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: No
• Has Expiration Date: Yes
• 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
42352	Subperiosteal dental implant material	A non-sterile material intended to be used, typically within a dental laboratory, to create a subperiosteal dental implant. It is typically in the form of a metallic ingot (e.g., titanium, cobalt-chrome-molybdenum) intended to be custom moulded for surgical implantation between the periosteum and the surface of the bone (subperiosteal frame) 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	05430000515115	GS1

Premarket Submissions

Submission Number	Supplement Number
K091051	000