AccessGUDID - DEVICE: Crown HT Unpigmented Single-unit Capsule 3-Pack (00850070544504)

GUDID

Device Identifier (DI) Information

Brand Name: Crown HT Unpigmented Single-unit Capsule 3-Pack
Version or Model: SRI-0204037
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sprintray, Inc.

Primary DI Number: 00850070544504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063005260 *Terms of Use

Device Description: SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

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:	No
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
EBF	Material, Tooth Shade, Resin
EBG	Crown And Bridge, Temporary, Resin
EBI	Resin, Denture, Relining, Repairing, Rebasing
ELM	Denture, Plastic, Teeth
PZY	Additively Manufactured, Preformed, Resin Denture Tooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242277	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 12 Milliliter

Device Record Status

Public Device Record Key: 60c1fadf-bbf0-4f31-8d12-89a1135d9c91
Public Version Date: March 05, 2025
Public Version Number: 1
DI Record Publish Date: February 25, 2025