LENTULO

Basic Information

• Brand Name: LENTULO
• Primary DI: 07640142420422
• Version / Model: 02.171.25.040.GM
• Catalog Number: 02.171.25.040.GM
• Company Name: FKG Dentaire Sàrl
• Labeler DUNS: 482884061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-14
• Public Version: 1
• Public Version Date: 2022-08-22
• Public Version Status: New
• Public Device Record Key: 27b42ea4-8486-4fc3-b5ec-7dcb543e523a

Device Description

Paste-Fillers, standard, 171, 25 mm, # 40, handle GM

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: Yes
• 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
EIY	Instrument, Filling, Plastic, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65738	Endodontic obturation material distribution endpiece, reusable	A dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640142420422	GS1