FDA.reportPublic FDA data

Glorysmile

Primary DI
06970016625648
Brand
Glorysmile
Company
Jiangxi Dentalbright Technology Co., Ltd
Model
GS-010YMN
Published
2024-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIDSyringe, Restorative And Impression Material

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970016625648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970016625648069700166256486970016625648

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544503502
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970016621824Non4002023-05-06
06970016623651Daniel3x2ml2023-03-25
06970016620643GlorySmileGS-0012022-12-21
06970016621404GlorySmileGS-003C/P/H2023-02-22
06970016621534GlorySmileGS-013H2023-02-22
06970016621831GlorySmileGS-SK2023-02-22
06970016621879GlorySmileGS-003Z2023-02-22
06970016622005GlorySmileGS-002W2023-02-22
06970016622807GlorySmileGS-JK2023-02-22
06970016622920GlorySmileGS-003B2023-02-22
06970016623057GlorySmileGS-002B2023-02-22
06970016623200GlorySmileGS-001YF2023-02-22
06970016623293GlorySmileGS-003-H2023-02-22
06970016623576GlorySmileGS-LB2023-02-22
06970016624030GlorySmileGS-0012023-02-22
06970016624481GlorySmileGS-001Y2023-02-22
06970016624887GlorySmileGS-012C2023-02-22
06970016625006GlorySmileGS-013VF2023-02-22
06970016625891GlorySmileGS-001C2023-02-22
06970016626140GlorySmileGS-001A2023-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998226724Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226731Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226748Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226755Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226762Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226847Solventum™ Garant™Solventum Germany GmbHEID2026-10-08
00810111542951AccessoryBISCO INC.EID2026-10-01
00883205041005Thermo CloneULTRADENT PRODUCTS, INC.EID2026-08-22
08800017902524EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
07615208353723Mixing TipsIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-08-19
00840456200940JMUJMU DENTAL, INCEID2026-07-20
00840456216743JMUJMU DENTAL, INCEID2026-07-20
00840456218198JMUJMU DENTAL, INCEID2026-07-20
00840456218204JMUJMU DENTAL, INCEID2026-07-20
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-07-14
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28