FDA.reportPublic FDA data

Digital Temp - A1 - Multi-Unit Capsule 3-Pack

Primary DI
00850070544887
Brand
Digital Temp - A1 - Multi-Unit Capsule 3-Pack
Company
Sprintray, Inc.
Model
SRI-0204183
Device description
SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
Published
2026-04-08
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
00850070544887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070544887008500705448878500705448870850070544887

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.

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
00810222900060SportsGuard - Crimson RedSRI-02021622026-06-23
00810222900077SportsGuard - Cobalt BlueSRI-02021632026-06-23
00810222900084SportsGuard - ClearSRI-02022182026-06-23
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322591Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322614Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322973Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09