FDA.reportPublic FDA data

Affinity™ Inflex FS 2-Pack

Primary DI
00359883001957
Brand
Affinity™ Inflex FS 2-Pack
Company
DEN-MAT HOLDINGS, LLC
Model
022405
Catalog number
022405
Device description
VPS Impression Material
Published
2025-03-12
Public version status
New
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
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00359883001957PrimaryGS10
00359883001940Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00359883001957003598830019573598830019570359883001957
00359883001940003598830019403598830019400359883001940

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
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment Temperature18 Degrees Celsius24 Degrees Celsius
Storage Environment Temperature65 Degrees Fahrenheit75 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00359883007218EVANESCE0322200322202025-10-08
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D8130304025501Cerinate®0304025500304025502016-09-24
D8131002AB0Ceri-Prime1002AB1002AB2016-09-24
D8131398B0Ceri-Prime1398B1398B2016-09-24
D81313990Ceri-Prime139913992016-09-24
D813402022B0Other402022B402022B2016-09-24
D8134020600Ceri-Prime4020604020602016-09-24
D81340213100Ceri-Prime402131040213102016-09-24
00359883007201EVANESCE0322550322552025-05-30
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00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit6419606419602025-03-18
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00359883002046Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883006273Final Shine Cotton Polishing Wheel 50-Pack1335001335002025-03-13
00359883006501Clinician's Choice® G5 Sample Pack9726059726052025-03-13

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