Diamodent

Basic Information

• Brand Name: Diamodent
• Primary DI: D907Z9000
• Version / Model: N/A
• Catalog Number: Z900
• 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: 1
• Public Version Date: 2019-02-04
• Public Version Status: New
• Public Device Record Key: 381cb9e3-c62f-48cf-ac2c-7d8c7ee4e7af

Device Description

Compatible with: 4.8mm Wide Neck (WN) ITI Straumann implants Implant Replica, Stainless Steel

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: No

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
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D907Z9001	HIBCC	Pouch	6	In Commercial Distribution
Primary	D907Z9000	HIBCC