HyperFIL™

Basic Information

• Brand Name: HyperFIL™
• Primary DI: 00810000525225
• Version / Model: S321
• Catalog Number: S321
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-26
• Public Version: 5
• Public Version Date: 2024-01-25
• Public Version Status: Update
• Public Device Record Key: 09aa159e-e5f9-439f-af15-b2dd9d55caa6
• Distribution End Date: 2021-03-02

Device Description

HyperFIL™ Intro Kit (Contains: Enamel & Universal HyperFIL™ plus dispensing gun)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810000525225	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Avoid execessive heat and moisture. Do not freeze. Bring to room temperature before use.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius