FDA.reportPublic FDA data

Try-In 2

Primary DI
10850039704151
Brand
Try-In 2
Company
Sprintray, Inc.
Model
SRI-0202031
Catalog number
SRI-0202031
Device description
Intended to be used to fabricate teeth models, which can be used for fabricating Try-In Dentures for cosmetic and not masticatory purposes.
Published
2022-02-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin
EEAPlate, Base, Shellac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
EEAPlate, Base, ShellacDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039704151PackageGS11In Commercial Distribution
00850039704154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003970415110850039704151
00850039704154008500397041548500397041540850039704154

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.

Sterilization Methods#

Method table
Method

Contacts#

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

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 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
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.EBH2026-06-04
06975527188408MOLEKURShanghai Coherz Technology Co., Ltd.EBH2026-06-04
D080XXTRR05KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
00197998216121Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216138Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216152Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216169Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216176Clarity™Solventum Orthodontics CorporationEBH2026-04-25
09359215000376DentaTRAY OrangeASIGA PTY LTDEBH2025-01-17
08800017902043Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
08800017902074Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
D248628000Surfactant 32ozHAGER WORLDWIDE, INC.EBH2023-07-13
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20386040012789COE®Gc America Inc.EBH2023-04-20