FDA.reportPublic FDA data

IDB 3

Primary DI
00850070544832
Brand
IDB 3
Company
Sprintray, Inc.
Model
SRI-0202219
Device description
SprintRay IDB 3 is a light-curable polymerizable resin intended to be used for the fabrication of indirect bonding trays. This material is an alternative to traditional IBT material.
Published
2026-03-17
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
QJJIndirect Bonding Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJJIndirect Bonding TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070544832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070544832008500705448328500705448320850070544832

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
063005260
Device count
1
Premarket exempt
true
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
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSRI-02041642026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSRI-02040442026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSRI-02041592026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSRI-02041602026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSRI-02041612026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSRI-02041622026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSRI-02041632026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSRI-02041742026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSRI-02040392026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSRI-02040402026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSRI-02040412026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSRI-02040422026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSRI-02040432026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSRI-02041732026-07-31
00850070544849Retainer - NaturalSRI-02022232026-07-29
00850070544856Retainer - BlackSRI-02022222026-07-29
00850070544863Retainer - PinkSRI-02022212026-07-29
00850070544870Retainer - Neon GreenSRI-02022202026-07-29
00810222900060SportsGuard - Crimson RedSRI-02021622026-06-23
00810222900077SportsGuard - Cobalt BlueSRI-02021632026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850061082029Custom Orthodontic SolutionKlowen Braces, Inc.QJJ2026-05-26
06956748704417Angel AlignerWuxi EA Medical Instruments Technologies Limited.QJJ2026-05-19
D9821716150LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716160LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716170LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716180LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716190LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
00860012928408CelebraceCelebrace Inc.QJJ2025-03-28
00850061082015Custom Digital OrthodonticsKlowen Braces, Inc.QJJ2024-11-21
09359215000055DentaIBTASIGA PTY LTDQJJ2024-02-06
D865REF06001ClearCorrect System Engager TemplateClearcorrect Operating, LLCQJJ2024-02-02
07290018915028MED610STRATASYS LTDQJJ2024-01-10
07290018915219MED610STRATASYS LTDQJJ2024-01-10
07290018915417MED610STRATASYS LTDQJJ2024-01-10
07290018915615MED610STRATASYS LTDQJJ2024-01-10
07290018915813MED610STRATASYS LTDQJJ2024-01-10
D865REF02001ClearCorrect SystemClearcorrect Operating, LLCQJJ2023-08-25
00816063022169Attachment TemplateAlign Technology, Inc.QJJ2023-07-24
D82854001600Indirect BondFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001610Indirect Bond W/Hard ShellFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001660Indirect Bond-EZ_HardSoftFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D8285401650Digital Indirect BondFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D918DOCWT0Digital Orthodontic CareDigital Orthodontic CareQJJ2022-12-09
H66842000081KeyPrintKeystone IndustriesQJJ2022-11-30
H66842200081KeyPrintKeystone IndustriesQJJ2022-11-30
D9821712500LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712510LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712520LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712530LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712730LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01