Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832HPCOVR1
• Version / Model: HP-COVR
• Catalog Number: HP-COVR
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-06-16
• Public Version: 1
• Public Version Date: 2022-06-24
• Public Version Status: New
• Public Device Record Key: efcb3bfd-5413-4676-ba3e-6d17ddb1ca76

Device Description

Handpiece Purge & Safety Cover, Clear

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: No
• 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63884	Surgical instrument protective cap	A small, non-sterile cover designed to be placed on the tip or working end of a surgical instrument to protect it from damage while not in use. It may be made of metal or synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D832HPCOVR2	HIBCC	Case	40	In Commercial Distribution
Primary	D832HPCOVR1	HIBCC
Unit of Use	D832HPCOVR0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K201604	000