FDA.reportPublic FDA data

OnX - A1

Primary DI
00850039704086
Brand
OnX - A1
Company
Sprintray, Inc.
Model
SRI-0202027
Catalog number
SRI-0202027
Device description
Full arch provisional restoration for all-on-x cases. Denture teeth for removable permanent full dentures
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
ELJTeeth, Artificial, Posterior With Metal Insert
ELKTeeth, Artificial, Backing And Facing
ELMDenture, Plastic, Teeth
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELJTeeth, Artificial, Posterior With Metal InsertDental1
ELKTeeth, Artificial, Backing And FacingDental1
ELMDenture, Plastic, TeethDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039704083PackageGS11In Commercial Distribution
00850039704086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003970408310850039704083
00850039704086008500397040868500397040860850039704086

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
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
D0804SCENZ100ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXB30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXC20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXC30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXD20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ100ULXD30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ103ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULA350CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULW050CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXA40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXB40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC10CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXC40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD20CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD30CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19
D0804SCENZ117ULXD40CROWN NS/EFUCERA NS 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-19