FDA.reportPublic FDA data

Fresh adhäsiv

Primary DI
E239D51141
Brand
Fresh adhäsiv
Company
Dreve Dentamid GmbH
Model
1
Catalog number
D5114
Device description
For the adhesion between impression tray and silicone impression material, high adhesion and still easy cleaning of the tray.20 ml bottle with brush insert for prefabricated metal or plastic trays. Colour: red.
Published
2016-10-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053427000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053427000FRESH, DENTAL IMPRESSION MATERIALExacta Dental Products, Inc.2006-01-13ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E239D51141PrimaryHIBCC0

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
388000846
Device count
1
Lot or batch
true
Expiration date on label
true

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