Enthus 38-00005

GUDID 10353045001813

Enthus VPS Impression Material, Heavy Body, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges

DHARMA RESEARCH, INC.

Silicone dental impression material

• Primary Device ID: 10353045001813
• NIH Device Record Key: a501bebf-77f2-49ee-a979-d7daf0785b9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enthus
• Version Model Number: 38-00005
• Catalog Number: 38-00005
• Company DUNS: 078444642
• Company Name: DHARMA RESEARCH, INC.
• Device Count: 4
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 8778333725
• Email: info@dharmaresearch.com

Device Dimensions

• Total Volume: 50 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353045001816 [Primary]
GS1	00353045002691 [Unit of Use]
GS1	10353045001813 [Package]; Contains: 00353045001816; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041028

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-07

On-Brand Devices [Enthus]

• 10353045001882: Enthus Bite Registration Fast Set, 2 x 50ml Cartridges & 6 Mixing Tips
• 10353045001875: Enthus Bite Registration, Regular Set, 2 x 50ml Cartridges & 6 Mixing Tips
• 10353045001868: Enthus VPS Impression Material, Monophase, Fast Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001851: Enthus VPS Impression Material, Heavy Body, Fast Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001844: Enthus VPS Impression Material, Medium Body, Fast Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001837: Enthus VPS Impression Material, Light Body, Fast Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001820: Enthus VPS Impression Material, Monophase, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001813: Enthus VPS Impression Material, Heavy Body, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001806: Enthus VPS Impression Material, Medium Body, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001790: Enthus VPS Impression Material, Light Body, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges
• 10353045001783: Enthus VPS Impression Material, Putty, Fast Set, Spearmint Flavor, 1 x 300ml Base, 1 x 300ml Cat
• 10353045001776: Enthus VPS Impression Material, Putty, Regular Set, Spearmint Flavor, 1 x 300ml Base, 1 x 300ml