Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832907DMS2N1
• Version / Model: 907DMS-2N
• Catalog Number: 907DMS-2N
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-01-14
• Public Version: 1
• Public Version Date: 2022-01-24
• Public Version Status: New
• Public Device Record Key: 5d98d6b2-be93-4b07-9827-cd5f556dd9a5

Device Description

Disposable Mixing Spatulas, Neon Blue

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: 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
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64028	Dental spatula, single-use	A sterile, hand-held manual dental device intended to be used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D832907DMS2N0	HIBCC
Primary	D832907DMS2N1	HIBCC