Honigum Mono Quad Fast

Primary DI
EDMG9998390
Brand
Honigum Mono Quad Fast
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
999839
Catalog number
999839
Device description
Impression material, medium-bodied consistency. Professional precision. Content: 4 cartridges @ 50 ml paste, Accessories
Published
2016-09-23
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000878000HONIGUMDmg USA, Inc.2000-04-11ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG9998391PackageHIBCC1In Commercial Distribution
EDMG9998398PackageHIBCC6In Commercial Distribution
EDMG9998390PrimaryHIBCC0

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
Special Storage Condition, Specify00Protect against exposure to direct sunlight!
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
201-894-5505eanagnostos@dmg-america.com

Regulatory Flags#

DUNS number
320744915
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

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EDMG1107190Luxatemp® Fluorescence1107191107192016-09-23
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