FDA.report

SHINING 3D®

Primary DI
06970163087375
Brand
SHINING 3D®
Company
Shining 3D Tech Co., Ltd.
Model
D48-A25-9-SH-48F
Published
2025-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06970163087375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06970163087375069701630873756970163087375

GMDN Terms

TermDefinition
Dental implant abutment analog, laboratoryA rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
529835314
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06970163089966SHINING 3D®Aoralscan Elite Wireless2026-03-23
06970163089973SHINING 3D®Aoralscan Elite Wireless2026-03-23
06970163089836SHINING 3D®Cra LF2026-03-16
06970163089812SHINING 3D®Aoralscan Elite Wireless2026-02-06
06970163089782SHINING 3D®SH-40A2026-02-05
06970163089799SHINING 3D®SH-43B2026-02-05
06970163089805SHINING 3D®SH-38A2026-02-05
06970163089546SHINING 3D®Aoralscan Elite Wireless2026-01-31
06970163089553SHINING 3D®Atip EB2026-01-31
06970163089560SHINING 3D®Atip EL2026-01-31
06970163089577SHINING 3D®Atip ES2026-01-31
06970163089416SHINING 3D®Atip EAB2026-01-01
06970163089430SHINING 3D®Atip EAL2026-01-01
06970163089447SHINING 3D®Atip EAS2026-01-01
06970163089454SHINING 3D®QC-A2026-01-01
06970163089409SHINING 3D®Aoralscan Elf (TS)2025-12-31
06970163089171SHINING 3D®DT-A2025-12-16
06970163089188SHINING 3D®ST-A2025-12-16
06970163089386SHINING 3D®DT-AS2025-12-16
06970163089195SHINING 3D®Aoralscan Lync2025-12-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
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