FDA.report

Galaxy Star

Primary DI
08800275828796
Brand
Galaxy Star
Company
ARUM DENTISTRY Co., Ltd.
Model
GUML525B2-WR
Published
2026-03-12
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

Related Records

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions

SubmissionSupplement
K250063000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250063000ARENA Star, Galaxy StarArum Dentistry Co., Ltd.2025-07-10EIH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800275828796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800275828796088002758287968800275828796

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods

Method

Regulatory Flags

DUNS number
557821945
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
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
08800055791203NB Master KitMAK-SET2026-03-24
08800055791210NB Regular Kit REK-SET2026-03-24
08800055792774Fixture Driver MachineFDM25M2026-03-24
08800055792781Fixture Driver MachineFDM31M2026-03-24
08800055792798Fixture Driver MachineFDM26R2026-03-24
08800055792804Fixture Driver MachineFDM32R2026-03-24
08800055792910Torque ExtensionTE012026-03-24
08800055792958Trial PinTP55132026-03-24
08800055792965Trial PinTP60132026-03-24
08800055792972Trial PinTP65132026-03-24
08800055792996Torque RatchetTR012026-03-24
08800265644320SD Surgical KitSDSK-SET2026-03-24
08800265645501Torque RatchetTR032026-03-24
08800265645532SD Multi Driver WrenchGSMD012026-03-24
08800265646492Guide Fixture Driver MachineGFDM31R2026-03-24
08800265646515SD Multi Driver MachineGSMD032026-03-24
08800265646522Anchor Screw Driver MachineGASDM2026-03-24
08800265646560Guide Fixture Driver MachineGFDM31M2026-03-24
08800275822800ARUM Prosthetic KitAPK-SET2026-03-24
08800275825498Torx Remover ToolTRTL2026-03-24

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