FDA.report

3D Dental - Mimic

Primary DI
00817169021995
Brand
3D Dental - Mimic
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
VPS-LF4
Device description
Mimic VPS Vinyl Polysiloxane Impression Material 4 Pack Light Body Fast Set
Published
2018-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817169021992PackageGS110In Commercial Distribution
20817169021999PackageGS130In Commercial Distribution
00817169021995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081716902199210817169021992
2081716902199920817169021999
00817169021995008171690219958171690219950817169021995

GMDN Terms

TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius23 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
080194935
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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