FDA.reportPublic FDA data

APEX Base - Original Pink - 3kg

Primary DI
00850070544429
Brand
APEX Base - Original Pink - 3kg
Company
Sprintray, Inc.
Model
SRI-0202192
Device description
SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Published
2025-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K221678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221678000SprintRay High Impact Denture BaseSprintray, Inc.2022-11-10EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070544429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070544429008500705444298500705444290850070544429

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
Weight3Kilogram

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
063005260
Device count
1
Lot or batch
true
Manufacturing date on label
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

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Primary DI, Brand, Company table
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07615208585841IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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