FDA.reportPublic FDA data

GlorySmile

Primary DI
06970016623576
Brand
GlorySmile
Company
Jiangxi Dentalbright Technology Co., Ltd
Model
GS-LB
Published
2023-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970016623576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970016623576069700166235766970016623576

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970016621824Non4002023-05-06
06970016623651Daniel3x2ml2023-03-25
06970016625648GlorysmileGS-010YMN2024-08-19
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
06970016624030GlorySmileGS-0012023-02-22
06970016624481GlorySmileGS-001Y2023-02-22
06970016624887GlorySmileGS-012C2023-02-22
06970016625006GlorySmileGS-013VF2023-02-22
06970016625891GlorySmileGS-001C2023-02-22
06970016626140GlorySmileGS-001A2023-02-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08