3D Dental -Mimic

GUDID 00817169021988

Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Heavy Body Regular Set

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Silicone dental impression material
Primary Device ID00817169021988
NIH Device Record Keyde8bdca5-8bf9-40b4-95fc-894edea8dcd8
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Dental -Mimic
Version Model NumberVPS-HR4
Company DUNS080194935
Company Name3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817169021988 [Primary]
GS110817169021985 [Package]
Package: Case/10 [10 Units]
In Commercial Distribution
GS120817169021982 [Package]
Package: Case/30 [30 Units]
In Commercial Distribution

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-30

On-Brand Devices [3D Dental -Mimic]

00817169022046Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack 4 Pack Medium Body Regular Set
00817169022039Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Medium Body Fast Set
00817169022022Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Monophase Regular Set
00817169022015Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Monophase Fast Set
00817169022008Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Light Body Regular Set
00817169021988Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Heavy Body Regular Set
00817169021971Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Heavy Body Fast
00817169022459TEMPORARY CROWN & BRIDGE MATERIAL 90GM 1:1 A3
00817169022442TEMPORARY CROWN & BRIDGE MATERIAL 90GM 1:1 A2
008171690221383D DENTAL CROWN & BRIDGE T-STYLE 10:1 & 4:1 50/BAG BLUE/ORANGE
008171690221213D DENTAL CROWN & BRIDGE T-STY 1:1 50/BAG BLUE/CLEAR
008171690221073D MIXPAC T MIXING TIP TEAL 48/PKG
008171690220913D MIXPAC T MIXING TIP PINK 48/PKG
008171690220843D MIXING TIP T BROWN CEMENT 25/BAG

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