OPERA SYSTEM®

GUDID 06970163082103

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	06970163082103
NIH Device Record Key	8714b3ee-ecc7-47aa-80fc-b2839637f99a
Commercial Distribution Status	In Commercial Distribution
Brand Name	OPERA SYSTEM®
Version Model Number	OS GOLDY
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	06970163082103 [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 [OPERA SYSTEM®]

06970163082691	The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
06970163080512	The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
06970163085135	The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t
06970163081229	This is a 3D face scanner that works with the supplied software programs. By performing facial s
06970163082103	The scanner is used to scan and capture the 3D characteristics of dental models including plaste

Trademark Results [OPERA SYSTEM]

Mark Image Registration \| Serial	Company Trademark Application Date
OPERA SYSTEM 75382684 not registered Dead/Abandoned	FemRx, Inc. 1997-10-30