FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06970163083797
Brand
SHINING 3D®
Company
Shining 3D Tech Co., Ltd.
Model
Surgical Guide Resin SG01
Published
2022-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OFYDental Implant Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970163083797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970163083797069701630837976970163083797

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529835314
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970163089140SHINING 3D®SN3D-AI2026-05-20
06970163084022SHINING 3D®AGR-AB2026-05-11
06970163084039SHINING 3D®AGR-AL2026-05-11
06970163084046SHINING 3D®AGR-AS2026-05-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116778662Zygomatic Surgical Kit, Standard Hex ADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-04-19
07290116770369Zygomatic surgical Kit, Standard Hex – TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-03-26
07290109308630Single TMA Open Tray TransferADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290109309927Guided Surgery Drills TRAYADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770000Guided Surgery Accessories TRAY– UNP&NPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770017Guided Surgery Accessories TRAY - RS ImplantsADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770024Guided Surgery Accessories TRAY– RP&WPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770291Guided Surgery Accessories KIT - UniFit Implants, TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772769Bone Autografting Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772776Bone Autografting Master SS Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772783OsseoSave Master NC Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772790OsseoSave Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116775494SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776507SS SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776514 SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776521SS SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116772967Bone Autografting Master SS Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773124OsseoSave Master Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773285OsseoSave Master NC Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116772806Bone Autografting Master KitADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-25
07640149888270TRITRI Dental Implants Int. AGOFY2025-11-10
07640149888324TRITRI Dental Implants Int. AGOFY2025-11-10
08435389826576COMPLETE SURGICAL BOX ADVANCED KITBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08435389828945STOP & GUIDE KIT; INTERNA IMPLANT; 3.0 PLATFORMBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08809918259980Surgical Option KitOssvis Co., Ltd.OFY2025-02-25
08435451660466KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660473KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660480KLOCKNERSOADCO, S.L.OFY2025-02-14
08809918259959Surgical Master Kit2Ossvis Co., Ltd.OFY2024-11-22
08809918259928Surgical Simple Kit2Ossvis Co., Ltd.OFY2024-10-25