FDA.reportPublic FDA data

Cavex Impressional Fast Set

Primary DI
E241AA0971
Brand
Cavex Impressional Fast Set
Company
Cavex Holland B.V.
Model
AA097
Catalog number
AA097
Device description
Dental Alginate Impression material
Published
2016-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E241AA0971PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight10Kilogram

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31(0)235307700r.woortman@cavex.nl

Regulatory Flags#

DUNS number
419980156
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E241FB3000Quadrant Uni-1-BondFB300FB3002026-03-30
E241FE1000Quadrant Total EtchFE100FE1002026-03-30
E241FU020Quadrant Universal LC starterkit syringesFU02FU022026-03-30
E241FU200Quadrant Universal LC syringes A1FU20FU202026-03-30
E241FU210Quadrant Universal LC syringes A2FU21FU212026-03-30
E241FU220Quadrant Universal LC syringes A3FU22FU222026-03-30
E241FU230Quadrant Universal LC syringes A3.5FU23FU232026-03-30
E241FU240Quadrant Universal LC syringes B2FU24FU242026-03-30
E241FU250Quadrant Universal LC syringes C2FU25FU252026-03-30
E241FU260Quadrant Universal LC syringes OA2FU26FU262026-03-30
E241FU270Quadrant Universal LC syringes IFU27FU272026-03-30
E241FU280Quadrant Universal LC syringes A4FU28FU282026-03-30
E241FU290Quadrant Universal LC syringes B3FU29FU292026-03-30
E241FU300Quadrant Universal LC syringes C3FU30FU302026-03-30
E241FU600Quadrant Universal LC capsule A1FU60FU602026-03-30
E241FU610Quadrant Universal LC capsule A2FU61FU612026-03-30
E241FU620Quadrant Universal LC capsule A3FU62FU622026-03-30
E241FU630Quadrant Universal LC capsule A3.5FU63FU632026-03-30
E241FU640Quadrant Universal LC capsule B2FU64FU642026-03-30
E241FU650Quadrant Universal LC capsule C2FU65FU652026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28