Cavex ImpreSafe refills HA050

GUDID E241HA0500

Dental impression disinfectant

Cavex Holland B.V.

Denture cleanser
Primary Device IDE241HA0500
NIH Device Record Key1fb9b25b-0477-4c9c-bdcc-7308f6b8f296
Commercial Distribution StatusIn Commercial Distribution
Brand NameCavex ImpreSafe refills
Version Model NumberHA050
Catalog NumberHA050
Company DUNS419980156
Company NameCavex Holland B.V.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl
Phone+31(0)235307700
Emailr.woortman@cavex.nl

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE241HA0500 [Primary]

FDA Product Code

LRJDisinfectant, Medical Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-07

Devices Manufactured by Cavex Holland B.V.

E241AA9050 - Cavex CleverCast - Slow Set2026-03-13 Lifecast Alginate Impression material
08719327516010 - Cavex CleverCast - Normal Set2026-03-13 Lifecast Alginate Impression material
E241BW0070 - Cavex Bite&White 3 syringes CP162026-03-13 Dental Whitening Agent
E241BW0080 - Cavex Bite&White 3 syringes CP222026-03-13 Dental Whitening Agent
E241BW0310 - Cavex Bite&White Ready 2 Use2026-03-13 Dental Whitening Agent
E241BW0500 - Cavex Bite&White In-Office 25% Starter 2026-03-13 Dental Whitening Agent
E241BW0510 - Cavex Bite&White In-Office 25% Pen bulk2026-03-13 Dental Whitening Agent
E241BW0520 - Cavex Bite&White In-Office 25% Barrier bulk2026-03-13 Dental Whitening Agent

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