SONICflex clean Tip No. 48 clean Tip No 48

GUDID EKAV057104010

This is a medical device.

Kaltenbach & Voigt GmbH

Ultrasonic dental scaling/debridement system
Primary Device IDEKAV057104010
NIH Device Record Key58c4f755-e4c5-4be9-93aa-cda30e20e23f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSONICflex clean Tip No. 48
Version Model Number0.571.0401
Catalog Numberclean Tip No 48
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 Batchtrue
Serial Numberfalse
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
HIBCCEKAV057104010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


[EKAV057104010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

On-Brand Devices [SONICflex clean Tip No. 48]

EKAV057104010This is a medical device.
EKAV100381670This is a medical device.

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