SprintRay High Impact Denture Teeth - B1

Basic Information

• Brand Name: SprintRay High Impact Denture Teeth - B1
• Primary DI: 00850039704338
• Version / Model: SRI-0202067
• Company Name: Sprintray, Inc.
• Labeler DUNS: 063005260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-05
• Public Version: 2
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 64cc332a-b517-4517-9cd8-98e80057c811

Device Description

SprintRay High Impact Denture Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	872.3590	2
ELM	Denture, Plastic, Teeth	Dental	872.3590	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
Package	10850039704335	GS1	Box	1	In Commercial Distribution
Primary	00850039704338	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	0.5	Liter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials. Do not store near high temperatures, light or ignition sources.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not store in an oxygen-free environment. Avoid freezing the material.