FDA.reportPublic FDA data

Elite HD+ Maxi Tray Material Fast Set

Primary DI
EZHIC2023201
Brand
Elite HD+ Maxi Tray Material Fast Set
Company
ZHERMACK SPA
Model
C202320
Catalog number
C202320
Device description
Addition silicone impression material
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
EZHIC2023201PrimaryHIBCC0
EZHIC2023200Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume760Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390425597611info@zhermack.com

Regulatory Flags#

DUNS number
432971034
Device count
2
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZHIC4016101Elite GlassC401610C4016102016-09-09
08056000372298Dynamic-static Mixing TipsC205530C2055302025-03-28
08056000372304Mixing TipsC202085C2020852025-03-28
08056000372311Mixing TipsC202086C2020862025-03-28
08056000372328Mixing TipsC202090C2020902025-03-28
08056000372465Dynamic-static Mixing TipsC205530C2055302025-03-28
08056000372434Mixing TipsC202085C2020852025-03-28
08056000372441Mixing TipsC202086C2020862025-03-28
08056000372472Mixing TipsC202090C2020902025-03-28
EZHIC3020250hydrogumC302025C3020252016-09-09
EZHIC2007261Occlufast RockC200726C2007262016-09-09
EZHIC2008001Occlufast CadC200800C2008002016-09-09
EZHIC2020201Elite HD+ Monophase Normal SetC202020C2020202016-09-09
EZHIC2020321Elite HD+ Tray Material Fast SetC202032C2020322016-09-09
EZHIC2023301Elite HD+ Maxi Tray Material Fast SetC202330C2023302016-09-09
EZHIC2030000Elite HD+ Putty Soft Normal SetC203000C2030002016-09-09
EZHIC2030021Elite HD+ Putty Soft Normal SetC203002C2030022016-09-09
EZHIC2030100Elite HD+ Putty Soft Fast SetC203010C2030102016-09-09
EZHIC2030121Elite HD+ Putty Soft Fast SetC203012C2030122016-09-09
EZHIC2030201Elite HD+ Regular Body Normal SetC203020C2030202016-09-09

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