HySil Plus Impression Materials

GUDID 08809917144638

Osstem Implant Co.,Ltd.

Silicone dental impression material
Primary Device ID08809917144638
NIH Device Record Keye72fa759-5cf5-406f-bda0-fdb06f552dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameHySil Plus Impression Materials
Version Model NumberESS50HS
Company DUNS694893867
Company NameOsstem Implant Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809917144638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-22
Device Publish Date2023-11-14

On-Brand Devices [HySil Plus Impression Materials]

08800121709309ESS50MSB
08800121709293ESS50HSB
08800121709286ESS50LSB
08800121709279ESS50LSD
08800121709262ESS50LS
08800121709255ESS50HS
08800121709248ESS380HS
08800121709231ESS50MS
08800121709224ESS50MSD
08800121709217ESS50HSD
08809917144638ESS50HS
08809917144621ESS50HSD
08809917144614ESS50HSB
08809917144607ESS50LS
08809917144591ESS50LSD
08809917144584ESS50LSB
08809917144577ESS50MS
08809917144560ESS50MSD
08809917144553ESS50MSB
08800121773621ESS380MS

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