FDA.reportPublic FDA data

Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material

Primary DI
D0026266001
Brand
Reprosil® Hydrophilic Vinyl Polysiloxane Impression Material
Company
DENTSPLY INTERNATIONAL INC.
Model
626600
Catalog number
626600
Device description
Reprosil® VPS Impression Material, Light Body (Orange), 4 (50ml) Cartridge Refill Package
Published
2016-09-21
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
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D00262660082PackageHIBCC8In Commercial Distribution
D0026266001PrimaryHIBCC0
D0026266000Unit 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 Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Storage Environment Temperature18 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
4
DM exempt
true
Lot or batch
true
Expiration date on label
true

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