Digital Temp Bleach Single-Unit Capsule 3-Pack

Primary DI
00850070544153
Brand
Digital Temp Bleach Single-Unit Capsule 3-Pack
Company
Sprintray, Inc.
Model
SRI-0204026
Device description
SprintRay Digital Temp is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed temporary full single crowns; temporary partial crowns in anterior and posterior area, individual and fixed single temporary 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.
Published
2025-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242559000Digital TempSprintray, Inc.2024-11-26EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070544153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070544153008500705441538500705441530850070544153

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA 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
TypeValueUnit
Total Volume12Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-914-8004support@sprintray.com

Regulatory Flags#

DUNS number
063005260
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810222900022OnX Tough 2 - A1 - Multi-Unit Capsule 3-PackSRI-02041972026-04-08
00810222900039OnX Tough 2 - Bleach - Multi-Unit Capsule 3-PackSRI-02042002026-04-08
00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSRI-02042422026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSRI-02042432026-04-08
00850070544764Digital Temp - A1 - Multi-Unit Capsule 1-PackSRI-02042162026-04-08
00850070544771Digital Temp - A2 - Multi-Unit Capsule 1-PackSRI-02042172026-04-08
00850070544788OnX Tough 2 - A1 - Multi-Unit Capsule 1-PackSRI-02042302026-04-08
00850070544795OnX Tough 2 - Bleach - Multi-Unit Capsule 1-PackSRI-02042332026-04-08
00850070544887Digital Temp - A1 - Multi-Unit Capsule 3-PackSRI-02041832026-04-08
00850070544931Crown HT - A1 - Multi-Unit Capsule 3-PackSRI-02042092026-04-08
00850070544948Crown HT - A2 - Multi-Unit Capsule 3-PackSRI-02042102026-04-08
00850070544993Digital Temp - A2 - Multi-Unit Capsule 3-PackSRI-02041842026-04-08
00850070544832IDB 3 SRI-02022192026-03-17
00850070544825Precision GuideSRI-02021892026-03-03
00850070544597APEX Flex - Standard PinkSRI-02021872025-07-21
00850070544603APEX Flex - Light PinkSRI-02021882025-07-21
00850070544320SprintRay Crown - A1 - Single-unit CapsuleSRI-02040922025-05-27
00850070544337SprintRay Crown - A2 - Single-unit CapsuleSRI-02040932025-05-27
00850070544344SprintRay Crown - A3 - Single-unit CapsuleSRI-02040942025-05-27
00850070544351SprintRay Crown - B1 - Single-unit CapsuleSRI-02040952025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02