Essentials by 3D Dental

Basic Information

• Brand Name: Essentials by 3D Dental
• Primary DI: 00810126506368
• Version / Model: 1
• Catalog Number: PC-BK
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Labeler DUNS: 080194935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-16
• Public Version: 1
• Public Version Date: 2025-12-24
• Public Version Status: New
• Public Device Record Key: 8fa4b4e5-a820-4a25-8d11-4c1fa50a9c66

Device Description

ESSENTIALS PLASTIC CUP 5OZ 1000/CS BLACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
KYX	DISPENSER, LIQUID MEDICATION	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44167	Drinking cup	A cup used by a patient or a staff member to give a patient or person a drink. It will typically be used on the ward and be made of durable materials, e.g., stainless steel or plastic materials, and will be designed as a regular open drinking cup with a handle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810126506368	GS1