FDA.reportPublic FDA data

Anterior Crown and Bridge Impression System Kit

Primary DI
00627843379584
Brand
Anterior Crown and Bridge Impression System Kit
Company
Moving Islands Transit Inc
Model
627843379584
Device description
Kit Contains: 6 x MiTi Heavy Body VPS Impression Material,1 x MiTi Light Body VPS Impression Material,18 x 88 mm Heavy Body Teal Mixing Tips,18 x 70 mm Light Body Yellow Mixing Tips,18 Intraoral Tips,18 MiTi Anterior Mesh Bite Trays
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627843379584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627843379584006278433795846278433795840627843379584

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material kit, reusableA collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and reusable application devices (e.g., cartridge gun), and might include a dental impression tray(s). Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a reusable device that may contain some disposable devices.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-900-6484mmahn@miticbs.com

Regulatory Flags#

DUNS number
202781316
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627843379591Posterior Crown and Bridge Impression System Kit6278433795912018-01-26
00627843379621Introduction Crown and Bridge Impression System Kit6278433796212018-01-26

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