SHINING 3D®

GUDID 06970163081878

The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can work with the supplied software to export the 3D scan data for CAD/CAM. the scan data can be apply for the orthodontic, restoration and implant.

Shining 3D Tech Co., Ltd.

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Primary Device ID	06970163081878
NIH Device Record Key	1da623de-790a-439c-b5c4-ffe094622741
Commercial Distribution Status	In Commercial Distribution
Brand Name	SHINING 3D®
Version Model Number	Capella M5
Company DUNS	529835314
Company Name	Shining 3D Tech Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970163081878 [Primary]

FDA Product Code

NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-07
Device Publish Date	2024-04-29

On-Brand Devices [SHINING 3D®]

06970163083803	Tray Resin TR01
06970163083797	Surgical Guide Resin SG01
06970163080390	The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
06970163080833	The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
06970163080192	This is a 3D face scanner that works with the supplied software programs. By performing facial s
06970163088013	This is a 3D face scanner that works with the supplied software programs. By performing facial s
06970163081878	The scanner is used to scan and capture the 3D characteristics of dental models including plaste

Trademark Results [SHINING 3D]

Mark Image Registration \| Serial	Company Trademark Application Date
SHINING 3D 90639924 not registered Live/Pending	Shining 3D Tech Co., Ltd. 2021-04-12
SHINING 3D 90639906 not registered Live/Pending	Shining 3D Tech Co., Ltd. 2021-04-12
SHINING 3D 90639885 not registered Live/Pending	Shining 3D Tech Co., Ltd. 2021-04-12