HySil Plus Impression Materials

GUDID 08809917144638

Osstem Implant Co.,Ltd.

Silicone dental impression material

• Primary Device ID: 08809917144638
• NIH Device Record Key: e72fa759-5cf5-406f-bda0-fdb06f552dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HySil Plus Impression Materials
• Version Model Number: ESS50HS
• Company DUNS: 694893867
• Company Name: Osstem Implant Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809917144638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210041

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [HySil Plus Impression Materials]

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