AmalgamBond®

Basic Information

• Brand Name: AmalgamBond®
• Primary DI: 00810000529049
• Version / Model: S375
• Catalog Number: S375
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-07
• Public Version: 2
• Public Version Date: 2023-01-10
• Public Version Status: Update
• Public Device Record Key: 705d50d9-6890-4157-9f5c-250a4f3d2b5d

Device Description

Accessory Kit AmalgamBond®: (1-Brush Handle, 100- Disposable Brush Tips, 1-Spatula, 3-Measuring Spoons, 2 mixing wells)

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: 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
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810000529049	GS1

Customer Contacts

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