PROPHYflex 4 Wave PROPHYflex 4 Wave

GUDID EKAV300280000

This is a medical device.

Kaltenbach & Voigt GmbH

Dental abrasive air jet system handpiece
Primary Device IDEKAV300280000
NIH Device Record Keyb437c9d9-2563-47d0-a249-c6f73551acb5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROPHYflex 4 Wave
Version Model Number3.002.8000
Catalog NumberPROPHYflex 4 Wave
Company DUNS332864359
Company NameKaltenbach & Voigt GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com
Phone+18475506800
Emailcustomerservice@kavo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV300280000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


[EKAV300280000]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-01
Device Publish Date2020-03-24

On-Brand Devices [PROPHYflex 4 Wave]

EKAV101194030This is a medical device.
EKAV300280000This is a medical device.

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