SprintRay Ceramic Crown - B1

Basic Information

• Brand Name: SprintRay Ceramic Crown - B1
• Primary DI: 00850039704451
• Version / Model: SRI-0202058
• Company Name: Sprintray, Inc.
• Labeler DUNS: 063005260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-25
• Public Version: 2
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 5019e61e-c3e7-4e69-9688-c1b9c2694775

Device Description

Intended for the fabrication of individual and fixed definitive full single crowns, definitive partial crowns, individual and fixed single veneers, and artificial teeth for dental prostheses.

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: 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
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	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	10850039704458	GS1	Box	1	In Commercial Distribution
Primary	00850039704451	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K222623	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.25	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.