FDA.reportPublic FDA data

Cavex ImpreSafe starterkit

Primary DI
E241HA0530
Brand
Cavex ImpreSafe starterkit
Company
Cavex Holland B.V.
Model
HA053
Catalog number
HA053
Device description
Dental impression disinfectant
Published
2016-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E241HA0530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleanserAn agent used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with, e.g., a toothbrush. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
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
20197344029317MEDLINEMEDLINE INDUSTRIES, INC.LRJ2026-04-27
04039239075462Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
04039239075479Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.LRJ2025-12-15
10197344169085MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
H816PSC050Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantMicroCare, LLCLRJ2025-10-23
08859335502220POSE HEALTH CARE LIMITED POSE HEALTH CARE LIMITEDLRJ2025-09-05
00615375013458CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00615375013472CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013455CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
00025469093455Ecolab Bleach Disinfectant WipeEcolab Inc.LRJ2025-05-09
00850065253244LIVE TULA Alcohol Pads 1.0 (100pcs/box)TULA HEALTH, INC.LRJ2025-03-18
06976301910710YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910727YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910734YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910741YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910758YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910765YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910772YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910789YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910796YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
10197344017690MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28