FDA.reportPublic FDA data

SprintRay Standard Denture Base - Bubblegum

Primary DI
10850039704281
Brand
SprintRay Standard Denture Base - Bubblegum
Company
Sprintray, Inc.
Model
SRI-0202092
Device description
SprintRay Standard Denture Base is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates.
Published
2023-01-05
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220979000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220979000SprintRay Denture BaseSprintray, Inc.2022-09-14EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039704281PackageGS11In Commercial Distribution
00850039704284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003970428110850039704281
00850039704284008500397042848500397042840850039704284

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, Specify00Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, Specify00Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials. Do not store near high temperatures, light or ignition sources.

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
false
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
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
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

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Primary DI, Brand, Company table
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06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
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