Home GUDID 10850039704380 SprintRay Standard Denture Teeth - B1
Primary DI 10850039704380
Brand SprintRay Standard Denture Teeth - B1
Company Sprintray, Inc.
Model SRI-0202036
Device description SprintRay Standard Denture Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures.
Published 2023-01-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PZY Additively Manufactured, Preformed, Resin Denture Tooth
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850039704380 Package GS1 1 In Commercial Distribution 00850039704383 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850039704380 10850039704380 00850039704383 00850039704383 850039704383 0850039704383
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 0.5 Liter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 o not store in an oxygen-free environment. Avoid freezing the material. Special Storage Condition, Specify 0 0 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.
Regulatory Flags# DUNS number 063005260 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850070544733 Motto Day 1 Tray 1 SRI-0202210 2026-08-21 00810222900046 Midas Restore - C2 - Single-unit Capsule 1-Pack SRI-0204164 2026-07-31 00810222900053 Midas Restore - C2 - Single-unit Capsule 3-Pack SRI-0204044 2026-07-31 00850070544610 Midas Restore - A1 - Single-unit Capsule 1-Pack SRI-0204159 2026-07-31 00850070544627 Midas Restore - A2 - Single-unit Capsule 1-Pack SRI-0204160 2026-07-31 00850070544634 Midas Restore - A3 - Single-unit Capsule 1-Pack SRI-0204161 2026-07-31 00850070544641 Midas Restore - B1 - Single-unit Capsule 1-Pack SRI-0204162 2026-07-31 00850070544658 Midas Restore - Bleach - Single-unit Capsule 1-Pack SRI-0204163 2026-07-31 00850070544665 Midas Restore - Unpigmented - Single-unit Capsule 1-Pack SRI-0204174 2026-07-31 00850070544672 Midas Restore - A1 - Single-unit Capsule 3-Pack SRI-0204039 2026-07-31 00850070544689 Midas Restore - A2 - Single-unit Capsule 3-Pack SRI-0204040 2026-07-31 00850070544696 Midas Restore - A3 - Single-unit Capsule 3-Pack SRI-0204041 2026-07-31 00850070544702 Midas Restore - B1 - Single-unit Capsule 3-Pack SRI-0204042 2026-07-31 00850070544719 Midas Restore - Bleach - Single-unit Capsule 3-Pack SRI-0204043 2026-07-31 00850070544726 Midas Restore - Unpigmented- Single-unit Capsule 3-Pack SRI-0204173 2026-07-31 00850070544849 Retainer - Natural SRI-0202223 2026-07-29 00850070544856 Retainer - Black SRI-0202222 2026-07-29 00850070544863 Retainer - Pink SRI-0202221 2026-07-29 00850070544870 Retainer - Neon Green SRI-0202220 2026-07-29 00810222900060 SportsGuard - Crimson Red SRI-0202162 2026-06-23
Other Devices Sharing Product Codes# 
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