Fluorescence Mode

Basic Information

• Brand Name: Fluorescence Mode
• Primary DI: 06909262100043
• Version / Model: 000000-2165-387
• Catalog Number: 000000-2165-387
• Company Name: Carl Zeiss Suzhou Co., Ltd.
• Labeler DUNS: 528182577
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-25
• Public Version: 3
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: 83050910-b412-4728-b6c3-f4b9931ff3e7

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
NBL	Laser, Fluorescence Caries Detection	Dental	872.1745	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62439	Dental surgical microscope	A light (optical) magnification instrument intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06909262100043	GS1

Premarket Submissions

Submission Number	Supplement Number
K171007	000