Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D8329000SESC0
• Version / Model: 9000SESC
• Catalog Number: 9000SESC
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 2
• Public Version Date: 2023-10-11
• Public Version Status: Update
• Public Device Record Key: 5e509d33-76a8-4d34-b5e7-4405ad8f4f6e
• Distribution End Date: 2023-10-10

Device Description

Screw-on SE Tip

Device Characteristics

• Single Use: No
• 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
EJB	Handle, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57822	Surgical irrigation/aspiration handpiece, reusable	A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8329000SESC0	HIBCC