FDA.report

die silicone

Primary DI
E22111861
Brand
die silicone
Company
VOCO GmbH
Model
1186
Catalog number
1186
Device description
This die silicone is an addition-curing silicone for the extraoral fabrication of dental models. Indirect composite restorations can be fabricated chairside on this silicone model. The die silicone’s special curing formula allows you ample time to apply the material. The material is fully cured after 4 minutes, at which time you can then start modelling the restorations.
Published
2019-06-06
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

Contact Domains

Product Codes

CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E22111861PrimaryHIBCC0
E2211186Unit of UseHIBCC0

GMDN Terms

TermDefinition
Polymer-based dental model materialA variety of dental materials dedicated for modelling and for use during production of dental restorations. It is based on various kinds of polymers. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags

DUNS number
316699578
Device count
2
DM exempt
false
Premarket exempt
true
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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