PermaSoft®

Basic Information

• Brand Name: PermaSoft®
• Primary DI: D001N8115000
• Version / Model: Soft Denture Liner Combination Kit
• Catalog Number: N811500
• Company Name: Dentsply International Inc.
• Labeler DUNS: 606173334
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 6
• Public Version Date: 2022-05-06
• Public Version Status: Update
• Public Device Record Key: 8b8fd45a-9f16-413f-b106-f3571feefb16
• Distribution End Date: 2022-05-05

Device Description

Contains one (1) 60 gram powder (Pink), one (1) 30 gram powder (Clear), one (1) 60 milliliter liquid, and one (1) 30 milliliter sealer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D001N8115000	HIBCC

Customer Contacts

• Phone: [phone] ext. 54660
• Email: [email protected]