3D Dental

Basic Information

• Brand Name: 3D Dental
• Primary DI: 00817169024088
• Version / Model: DMW-2
• Catalog Number: DMW-2
• 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: 2023-01-05
• Public Version: 1
• Public Version Date: 2023-01-13
• Public Version Status: New
• Public Device Record Key: e414637d-df07-4e26-a8dd-2ae426000ac6

Device Description

Disposable Mixing Well 2-Well 200/Bx

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: No
• 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
KXR	Applicator, Resin	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45120	Dappen dish, single-use	A small, shallow concave vessel made of a thermoplastic material used to mix dental materials chairside prior to application to the patient during dental procedures. The device is typically placed in a holder while the user dispenses the required amount of component materials into it and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. The device will then be placed in a hand-held holder for patient application. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817169024088	GS1