LMDental

Basic Information

• Brand Name: LMDental
• Primary DI: 06438311707129
• Version / Model: 481-487DDES
• Company Name: LM-Dental
• Labeler DUNS: 401969969
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-01
• Public Version: 2
• Public Version Date: 2023-10-23
• Public Version Status: Update
• Public Device Record Key: 8d390713-03d1-4bed-b96c-be34b106184e

Device Description

Arte Fissura DD

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38530	Dental spatula, reusable	A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438311707129	GS1