SURGmatic S201 XL Pro S201 XL Pro

GUDID EKAV101375410

This is a medical device.

Kaltenbach & Voigt GmbH

Dental power tool system handpiece, line-powered
Primary Device IDEKAV101375410
NIH Device Record Keycce23427-5e8f-4d31-a790-961d27c6dcbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGmatic S201 XL Pro
Version Model Number1.013.7541
Catalog NumberS201 XL Pro
Company DUNS332864359
Company NameKaltenbach & Voigt GmbH
Device Count1
DM Exempttrue
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+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com
Phone+18882755286
Emailcustomerservice@kavo.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV101375410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


[EKAV101375410]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2020-01-24

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