Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832XR08611
• Version / Model: XR-0861
• Catalog Number: XR-0861
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-02-14
• Public Version: 1
• Public Version Date: 2022-02-22
• Public Version Status: New
• Public Device Record Key: 3ce7b2e5-246b-42ef-a933-c0f8d7ce07bb

Device Description

Anterior Bite Blocks, Blue

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
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31828	Dental x-ray system beam alignment device	A mechanical device that is used to support and position dental x-ray film and to serve as a guide for proper physical alignment of the x-ray tube with the positioned dental x-ray film during dental x-ray imaging procedures. Depending on the device design, it can be used as a guide for either intraoral or extraoral dental x-ray systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D832XR08610	HIBCC
Primary	D832XR08611	HIBCC