CERTAIN® PROVIDE®

Basic Information

• Brand Name: CERTAIN® PROVIDE®
• Primary DI: 00844868013891
• Version / Model: PAK6340
• Company Name: BIOMET 3I, LLC
• Labeler DUNS: 186127825
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-10
• Public Version: 3
• Public Version Date: 2022-03-10
• Public Version Status: Update
• Public Device Record Key: 0ecd00df-4be2-47dd-8b7b-a14a405c97e9
• Distribution End Date: 2016-08-10

Device Description

CERTAIN® PROVIDE® ABUTMENT PLACEMENT KIT 6.0MM(D) X 6.5MM(P) X 3MM(H) - 4.0MM POST

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: No
• 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
NHA	ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS	Dental	872.3630	2

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	00844868013891	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	3	Millimeter
Device Size Text, specify			Post Height 4 mm
Device Size Text, specify			Diameter 6 mm