Diamodent

Basic Information

• Brand Name: Diamodent
• Primary DI: D907AB9100
• Version / Model: N/A
• Catalog Number: AB910
• 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: 5e704555-0643-4cac-ba5c-79525e333354

Device Description

Compatible with: 4.3mm Regular Platform (RP) NobelReplace implants Implant Replica, Aluminum, Yellow

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	D907AB9102	HIBCC	Pouch	12	In Commercial Distribution
Primary	D907AB9100	HIBCC
Package	D907AB9101	HIBCC	Pouch	6	In Commercial Distribution