OCCLUSAL 4C REFILL KIT

Basic Information

• Brand Name: OCCLUSAL 4C REFILL KIT
• Primary DI: 06430035873388
• Version / Model: 900802-DEX
• Company Name: PaloDEx Group Oy
• Labeler DUNS: 459955188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-23
• Public Version: 1
• Public Version Date: 2025-12-31
• Public Version Status: New
• Public Device Record Key: 4103d495-53ec-4338-a4d1-71a4375a1765

Device Description

OCCLUSAL 4C REFILL KIT

Device Characteristics

• Single Use: Yes
• 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: 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66696	Dental digital imaging phosphor plate intraoral cover	An intraoral device in the form of an envelope or sleeve intended to cover a digital imaging phosphor plate prior to introduction into the oral cavity, to prevent cross-contamination between patients and/or shield the plate from ambient light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06430035873388	GS1

Premarket Submissions

Submission Number	Supplement Number
K133231	000