Chemoment

GUDID 06976009588884

Chemoment Materials Co., Ltd.

Silicone dental impression material

• Primary Device ID: 06976009588884
• NIH Device Record Key: c3ae6833-8c24-4971-b7ce-d8efa933f111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chemoment
• Version Model Number: 8
• Company DUNS: 528179019
• Company Name: Chemoment Materials 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976009588884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221668

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-13
• Device Publish Date: 2025-04-15

On-Brand Devices [Chemoment]

• 06976009581113: 1
• 06976009589997: 9
• 06976009588884: 8
• 06976009587771: 7
• 06976009586668: 6
• 06976009585555: 5
• 06976009584442: 4
• 06976009583339: 3
• 06976009582226: 2
• 06976009581120: 12
• 06976009581106: 10