RMH3 Dental

GUDID 00850072425054

EcoPression VPS Heavy Body Impression Material – Regular Set, 4 x 50 mL Cartridges

Chemoment Materials Co., Ltd.

Silicone dental impression material

• Primary Device ID: 00850072425054
• NIH Device Record Key: e0e406a3-3098-491b-ad93-50c662c5680e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RMH3 Dental
• Version Model Number: type 1
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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	00850072425054 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-13
• Device Publish Date: 2025-03-05