BioHorizons

Basic Information

• Brand Name: BioHorizons
• Primary DI: 00847236023935
• Version / Model: PYBPGP
• Company Name: BIOHORIZONS IMPLANT SYSTEMS, INC
• Labeler DUNS: 967279910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-20
• Public Version: 1
• Public Version Date: 2023-07-28
• Public Version Status: New
• Public Device Record Key: c1b98125-a27b-40f4-ae00-027f12e30b3c

Device Description

3.5mm Bone Profiler Guide Pin (pack of 4)

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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
46552	Dental implantation drilling template retention pin	A small, metal peg designed to provide initial stability to anchor a custom-made surgical template that is fitted over the ridge of existing teeth and/or gum of a patient during the first stage of a dental implantation procedure. It is inserted through lateral guide hole(s) in the template, and is pressed into pre-drilled hole(s) in the jawbone. It is used for implantation procedures where a tooth/teeth are missing and a template is used to provide the dentist with the correct drilling position(s) for the implant(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847236023935	GS1