HySil Impression Materials (Heavy, Mono, and Bite)

GUDID 08800121720007

Osstem Implant Co.,Ltd.

Silicone dental impression material

• Primary Device ID: 08800121720007
• NIH Device Record Key: c56d9900-afa8-40b5-8f00-9bfb5db10fd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HySil Impression Materials (Heavy, Mono, and Bite)
• Version Model Number: ESS380H
• 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	08800121720007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181236

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: 2023-05-18
• Device Publish Date: 2023-05-10

On-Brand Devices [HySil Impression Materials (Heavy, Mono, and Bite)]

• 08800121720014: ESS380M
• 08800121720007: ESS380H