Diamodent

Basic Information

• Brand Name: Diamodent
• Primary DI: D907AJ6500
• Version / Model: N/A
• Catalog Number: AJ650
• Company Name: DIAMODENT INC
• Labeler DUNS: 013827410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-04
• Public Version: 2
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: ec5b74fe-d96b-423c-b22b-c0a02b5fa0f6

Device Description

Compatible with: 3.4mm, 4.1mm, 5.0mm, and 6.0mm Platform Internal BIOMET 3i Certain implants Small Diameter ComScrew Titanium, 1.2mm (.048") Hex, 20Ncm

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: 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: Yes
• Sterilization Methods: Dry Heat 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
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D907AJ6502	HIBCC	Pouch	12	In Commercial Distribution
Primary	D907AJ6500	HIBCC
Package	D907AJ6501	HIBCC	Pouch	6	In Commercial Distribution