ENGAGE PROSTHETIC KIT

Basic Information

• Brand Name: ENGAGE PROSTHETIC KIT
• Primary DI: D78560EPK0
• Version / Model: 6.0 ENGAGE PROSTHETIC KIT
• Catalog Number: 6.0 EPK
• Company Name: OCO BIOMEDICAL INC
• Labeler DUNS: 094146123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-27
• Public Version: 2
• Public Version Date: 2024-07-17
• Public Version Status: Update
• Public Device Record Key: 28870a0d-5034-4d63-88e6-0f1acd854c85

Device Description

6.0 ENGAGE PROSTHETIC KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
44881	Dental implant suprastructure kit	A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D78560EPK0	HIBCC