AccessGUDID - DEVICE: SprintRay OnX Tough

GUDID

Device Identifier (DI) Information

Brand Name: SprintRay OnX Tough - B1
Version or Model: SRI-0202119
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SRI-0202119
Company Name: Sprintray, Inc.

Primary DI Number: 00850039704529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063005260 *Terms of Use

Device Description: The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZY	Additively Manufactured, Preformed, Resin Denture Tooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Weight: 1 Kilogram

Device Record Status

Public Device Record Key: aec2a2a9-2bba-45be-a3c3-3ce782415d63
Public Version Date: February 29, 2024
Public Version Number: 2
DI Record Publish Date: May 08, 2023