FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06975338700264
Brand
SHINING 3D®
Company
Hangzhou SHINING3D Dental Technology Co., Ltd.
Model
CB11-B3
Device description
The product is used for 3D printing denture teeth.
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975338700264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975338700264069753387002646975338700264

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
Liquid Chemical

Regulatory Flags#

DUNS number
406871432
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
06975338701063SHINING 3D®CX200-A1 (0.5kg/bottle)2026-05-11
06975338701070SHINING 3D®CX200-A2 (0.5kg/bottle)2026-05-11
06975338701087SHINING 3D®CX200-B1 (0.5kg/bottle)2026-05-11
06975338701094SHINING 3D®CX200-BL (0.5kg/bottle)2026-05-11
06975338701599SHINING 3D®CB200-A1(Nano,6g,3-pack)2026-03-30
06975338701605SHINING 3D®CB200-A2(Nano,6g,3-pack)2026-03-30
06975338701612SHINING 3D®CB200-B1(Nano,6g,3-pack)2026-03-30
06975338701629SHINING 3D®CB200-C2(Nano,6g,3-pack)2026-03-30
06975338701636SHINING 3D®CB200-BL(Nano,6g,3-pack)2026-03-30
06975338702060SHINING 3D®CB200-A1 (0.5kg/bottle)2026-03-30
06975338702077SHINING 3D®CB200-A2 (0.5kg/bottle)2026-03-30
06975338702084SHINING 3D®CB200-B1 (0.5kg/bottle)2026-03-30
06975338702091SHINING 3D®CB200-BL (0.5kg/bottle)2026-03-30
06975338702107SHINING 3D®CB200-C2 (0.5kg/bottle)2026-03-30
06975338702268SHINING 3D®CB200-A1(Nano,10g,3-pack)2026-03-30
06975338702275SHINING 3D®CB200-A2(Nano,10g,3-pack)2026-03-30
06975338702282SHINING 3D®CB200-B1(Nano,10g,3-pack)2026-03-30
06975338702299SHINING 3D®CB200-C2(Nano,10g,3-pack)2026-03-30
06975338702305SHINING 3D®CB200-BL(Nano,10g,3-pack)2026-03-30
06975338702466SHINING 3D®CB200-A1(Nano,35g,3-pack)2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZIRKONZAHN SRLPZY2026-05-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPZY2026-04-13
00810222900022OnX Tough 2 - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00810222900039OnX Tough 2 - Bleach - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544788OnX Tough 2 - A1 - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544795OnX Tough 2 - Bleach - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544931Crown HT - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544948Crown HT - A2 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
08056865154466ACRY NATURE AFG 6 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155647ACRY NATURE AFG 6 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155654ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155661ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17