FDA.reportPublic FDA data

SportsGuard - Cobalt Blue

Primary DI
00810222900077
Brand
SportsGuard - Cobalt Blue
Company
Sprintray, Inc.
Model
SRI-0202163
Device description
SprintRay Sports Guard resin is a light-curable, polymerizable material intended for the fabrication of appliances that cover the teeth and adjacent oral tissues to help prevent or reduce trauma to teeth, gingiva, lips, and jaws during athletic or recreational activities.
Published
2026-06-23
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810222900077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810222900077008102229000778102229000770810222900077

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.

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
true
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
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
00810222900084SportsGuard - ClearSRI-02022182026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054154160013EQUILIBRATORE 1.0EPTAMED SRLKMY2026-07-28
08054154160020EQUILIBRATORE 1.05EPTAMED SRLKMY2026-07-28
08054154160037EQUILIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154160051EQUILIBRATORE 1.2 YOUNGEPTAMED SRLKMY2026-07-28
08054154160143EQUILIBRATORE 3.2EPTAMED SRLKMY2026-07-28
08054154160150EQULIBRATORE 3.3EPTAMED SRLKMY2026-07-28
08054154160198EquiIlibratore C2EPTAMED SRLKMY2026-07-28
08054154160204Equilibratore C3EPTAMED SRLKMY2026-07-28
08054154160211Equilibratore C4EPTAMED SRLKMY2026-07-28
08054154160228EQUILIBRATORE C3PEPTAMED SRLKMY2026-07-28
08054154160259EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160266EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160273EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160297FREEDOMEPTAMED SRLKMY2026-07-28
08054154160303EQUILIBRATORE GENIUS 3EPTAMED SRLKMY2026-07-28
08054154160334EQUILIBRATORE NIKI 1EPTAMED SRLKMY2026-07-28
08054154160372EQUILIBRATORE 003EPTAMED SRLKMY2026-07-28
08054154160402EQUILIBRATORE SL3 YOUNGEPTAMED SRLKMY2026-07-28
08054154160426EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160433EQUILIBRATORE U4EPTAMED SRLKMY2026-07-28
08054154160501EQULIBRATORE U2EPTAMED SRLKMY2026-07-28
08054154160563EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160761EQUILIBRATORE NIKI 2EPTAMED SRLKMY2026-07-28
08054154160815EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160822EQUILIBRATORE GENIUS 2EPTAMED SRLKMY2026-07-28
08054154160945EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160969EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154161089EQULIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154161126EQUILIBRATORE C3P YOUNGEPTAMED SRLKMY2026-07-28
08054154161164EQULIBRATORE U4 YOUNGEPTAMED SRLKMY2026-07-28