FDA.reportPublic FDA data

IDB 2

Primary DI
00850039704055
Brand
IDB 2
Company
Sprintray, Inc.
Model
SRI-0202012
Catalog number
SRI-0202012
Device description
Indicated for the fabrication, by additive manufacturing, of Indirect Bonding Tray
Published
2022-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin
QJJIndirect Bonding Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
QJJIndirect Bonding TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039704052PackageGS11In Commercial Distribution
00850039704055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003970405210850039704052
00850039704055008500397040558500397040550850039704055

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 Volume1Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSRI-02040642026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSRI-02040652026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSRI-02040682026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSRI-02040672026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSRI-02040332026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSRI-02040342026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSRI-02040662026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSRI-02040322026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSRI-02040632026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSRI-02040372026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSRI-02040302026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSRI-02040312026-10-09
00850070544733Motto Day 1 Tray 1SRI-02022102026-08-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412313088Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412313095Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320192Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320222Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320413Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320420Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320437Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679033Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679040Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679057Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679064Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679309Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679927Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
08800017902395Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902401Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902418Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902425Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902432Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
D14307560147448590Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBH2026-07-23
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09