FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06970163087672
Brand
SHINING 3D®
Company
Shining 3D Tech Co., Ltd.
Model
MetiSmile-MR
Device description
The product uses optical scanning method to collect facial 3D data and jaw movement tracking data to provide 3D digital models for facial and oral CAD design.
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFSDevice, Jaw Tracking, For Monitoring Jaw PositionsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970163087672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970163087672069701630876726970163087672

GMDN Terms#

Term, Definition table
TermDefinition
Jaw physiology evaluation systemAn assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""Moist Heat or Steam Sterilization""]"
Liquid Chemical;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529835314
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
06970163085968SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-05-23
06970163084213SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-03-15
06970163081489MARATHON®Shining 3D Tech Co., Ltd.NFS2023-10-13
B915015705101Inductive Charger JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705201Inductive Charger Tizian JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705401Inductive Charger ARCUSdigma IIIzebris MEDICAL GmbHNFS2023-10-04
B915015705501Inductive Charger zebris for ceramillzebris MEDICAL GmbHNFS2023-10-04
B915015705701Inductive Charger PlaneAnalyser IIzebris MEDICAL GmbHNFS2023-10-04
06970163081229Opera System®Shining 3D Tech Co., Ltd.NFS2023-08-23
B915015700521zebris for ceramill USB-Lzebris MEDICAL GmbHNFS2023-07-24
B915011700230Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915011700410ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915011700510zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915011700720PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
B915015700131JMA Optic USB-Lzebris MEDICAL GmbHNFS2023-07-20
B915015700231Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915015700411ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915015700511zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915015700721PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
B915019602500Para-occlusal Attachment with Lip Archzebris MEDICAL GmbHNFS2023-07-13
B915019602510Para-occlusal Attachment with Lip Arch AGzebris MEDICAL GmbHNFS2023-07-13
B915019602550Para-occlusal Attachment with Support Surfacezebris MEDICAL GmbHNFS2023-07-13
B915019602560Para-occlusal Attachment with Support Surface AGzebris MEDICAL GmbHNFS2023-07-13
B915019602600Para-occlusal Attachmentzebris MEDICAL GmbHNFS2023-07-13
B915019602800Occlusal Attachment UNzebris MEDICAL GmbHNFS2023-07-13
B915019603300Bite Fork Type SI / Fusion Bitezebris MEDICAL GmbHNFS2023-07-13
B915019603410Bite Fork PS1 zebris MEDICAL GmbHNFS2023-07-13
B915019603600Bite Fork UN zebris MEDICAL GmbHNFS2023-07-13
B915019604000Bite Fork Adapter / Fusion Bite Adapterzebris MEDICAL GmbHNFS2023-07-13
B915019604200Bite Fork Adapter UNzebris MEDICAL GmbHNFS2023-07-13