Yomi S Extra Oral Fiducial Array LRUL

Basic Information

• Brand Name: Yomi S Extra Oral Fiducial Array LRUL
• Primary DI: 00810004900646
• Version / Model: DRW-2824-02
• Company Name: NEOCIS INC
• Labeler DUNS: 802312434
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-01
• Public Version: 1
• Public Version Date: 2025-12-09
• Public Version Status: New
• Public Device Record Key: 6a09d8a8-8f0c-4c40-a7da-4b983c9e5e26

Device Description

Yomi S Extra Oral Fiducial Array LRUL

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: Yes
• Has Lot/Batch Number: No
• 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
PLV	Dental Stereotaxic Instrument	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45197	Dental stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during dental surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810004900646	GS1

Premarket Submissions

Submission Number	Supplement Number
K252376	000