FDA.reportPublic FDA data

SprintRay OnX Tough - A1

Primary DI
00850039704512
Brand
SprintRay OnX Tough - A1
Company
Sprintray, Inc.
Model
SRI-0202118
Catalog number
SRI-0202118
Device description
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Published
2023-05-08
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
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039704512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039704512008500397045128500397045120850039704512

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
Weight1Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, Specify00Do not store near high temperatures, light or ignition sources. 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
Premarket exempt
true
Lot or batch
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
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZIRKONZAHN SRLPZY2026-05-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPZY2026-04-13
00810222900022OnX Tough 2 - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00810222900039OnX Tough 2 - Bleach - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544788OnX Tough 2 - A1 - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544795OnX Tough 2 - Bleach - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544931Crown HT - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544948Crown HT - A2 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
08056865154466ACRY NATURE AFG 6 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155647ACRY NATURE AFG 6 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155654ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155661ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17