Enthus 38-00010

GUDID 10353045001868

Enthus VPS Impression Material, Monophase, Fast Set, Spearmint Flavor, 4 x 50ml Cartridges

DHARMA RESEARCH, INC.

Silicone dental impression material
Primary Device ID10353045001868
NIH Device Record Key230aa96e-6ff4-42c1-8505-ac148c6e073c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnthus
Version Model Number38-00010
Catalog Number38-00010
Company DUNS078444642
Company NameDHARMA RESEARCH, INC.
Device Count4
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8778333725
Emailinfo@dharmaresearch.com

Device Dimensions

Total Volume50 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100353045001861 [Primary]
GS100353045002745 [Unit of Use]
GS110353045001868 [Package]
Contains: 00353045001861
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-07

On-Brand Devices [Enthus]

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

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