PROPHYflex 4 S Lime 4 S Lime

GUDID EKAV300459300

This is a medical device.

Kaltenbach & Voigt GmbH

Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece
Primary Device IDEKAV300459300
NIH Device Record Key2dcf95e4-62e2-43c1-a4b7-92566140ebc4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROPHYflex 4 S Lime
Version Model Number3.004.5930
Catalog Number4 S Lime
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV300459300 [Primary]

FDA Product Code

EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


[EKAV300459300]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-12
Device Publish Date2020-03-04

Devices Manufactured by Kaltenbach & Voigt GmbH

EKAV101167860 - Elements 8:12021-03-15 This is a medical device.
EKAV100381670 - SONICflex clean Tip No. 482021-03-09 This is a medical device.
EKAV100729710 - Prophylaxe Set 20032021-03-09
EKAV100765500 - Prophylaxe Set 2008L/2018 violett2021-03-09
EKAV100957450 - SMART LUX Case 619460L2021-03-09
EKAV100957460 - SMART Case 619460C2021-03-09
EKAV100957640 - PROPHYflex Perio Powder 20gr.2021-03-09
EKAV100960480 - EXPERT LUX Case 680465LRN2021-03-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.