RMH3 Dental

GUDID 00850072425153

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

Chemoment Materials Co., Ltd.

Silicone dental impression material

• Primary Device ID: 00850072425153
• NIH Device Record Key: 2f75e741-c909-4082-89df-c49889543a14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RMH3 Dental
• Version Model Number: 93000
• 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	00850072425153 [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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [RMH3 Dental]

• 00850072425054: EcoPression VPS Heavy Body Impression Material – Regular Set, 4 x 50 mL Cartridges
• 00850072425153: EcoPression VPS Heavy Body Impression Material – Regular Set, 4 x 50 mL Cartridges
• 00850072425146: EcoPression VPS Putty Kit Base & Catalyst - Fast Set 400gr x 2
• 00850072425139: EcoPression VPS Putty Kit Base & Catalyst - Regular Set 400gr x 2
• 00850072425122: EcoPression Bite Registration Material – Super Fast Set, 2 x 50 mL Cartridges
• 00850072425115: EcoPression Bite Registration Material – Fast Set, 2 x 50 mL Cartridges
• 00850072425108: EcoPression VPS Medium Body Impression Material – Fast Set, 4 x 50 mL Cartridges
• 00850072425092: EcoPression VPS Medium Body Impression Material – Regular Set, 4 x 50 mL Cartridges
• 00850072425085: EcoPression VPS Light Body Impression Material – Fast Set, 4 x 50 mL Cartridges
• 00850072425078: EcoPression VPS Light Body Impression Material – Regular Set, 4 x 50 mL Cartridges
• 00850072425061: EcoPression VPS Heavy Body Impression Material – Fast Set, 4 x 50 mL Cartridges