Essentials by 3D Dental

Basic Information

• Brand Name: Essentials by 3D Dental
• Primary DI: 00817169022862
• Version / Model: B2-SG
• Catalog Number: B2-SG
• 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: 2023-02-21
• Public Version: 1
• Public Version Date: 2023-03-01
• Public Version Status: New
• Public Device Record Key: b64920c0-5019-45a8-be3e-13faeef81aee

Device Description

Patient Bibs 2PLY+POLY 13X18 GRAY 500/Case

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: 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: 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
KHR	ABSORBER, SALIVA, PAPER	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61050	Dental bib	A non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817169022862	GS1

Customer Contacts

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