EDS Core Forms

Basic Information

• Brand Name: EDS Core Forms
• Primary DI: 00766054001294
• Version / Model: 890-00
• Catalog Number: 890-00
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Labeler DUNS: 101147171
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 1
• Public Version Date: 2020-07-27
• Public Version Status: New
• Public Device Record Key: d35ee18d-475f-42dd-9d83-92fdecfe7db8

Device Description

48 Clear Core Forms

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• 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
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42344	Dental mould	A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766054001294	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]