FDA.reportPublic FDA data

Tube Set S600

Primary DI
EKAV100987570
Brand
Tube Set S600
Company
KaVo Dental GmbH
Model
1.009.8757
Catalog number
S600
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBWCONTROLLER, FOOT, HANDPIECE AND CORD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140308000MASTERSURG / EXPERTSURGKaltenbach & Voigt GmbH2014-08-15EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100987570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac ablation system irrigation tubing setA collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18475506800customerservice@kavo.com

Regulatory Flags#

DUNS number
333710619
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV057405000DIAGNOdent 20950.574.050020952016-09-26
EKAV100059540RONDOflex powder 50m (75g)1.000.5954NA2016-09-26
EKAV100059550RONDOflex powder 27m (75g)1.000.5955NA2016-09-26
EKAV100059560RONDOflex powder 50m (1000g)1.000.5956NA2016-09-26
EKAV100059570RONDOflex powder 27m (1000g)1.000.5957NA2016-09-26
EKAV100720000SonicFill Handpiece 349201.007.2000349202016-09-26
EKAV100620270SONICflex implant set A1.006.20271.006.20272025-01-31
EKAV100863840SONICflex prep crown round no. 97 A1.008.63841.008.63842025-01-31
EKAV100863860SONICflex prep crown plain no. 98 A1.008.63861.008.63862025-01-31
EKAV101537000DIAGNOcam Vision Full HD1.015.37001.015.37002024-12-03
EKAV100835000EXPERTsurg LUX1.008.35001.008.35002016-09-26
EKAV100880000INTRA LUX S600 LED1.008.80001.008.80002016-09-26
EKAV100910100SURGmatic S11 L1.009.10101.009.10102016-09-26
EKAV101375400SURGmatic S201 L Pro1.013.75401.013.75402020-01-24
EKAV101375410SURGmatic S201 XL Pro1.013.75411.013.75412020-01-24
EKAV101112130DIAGNOcam Vision Full HD1.011.12131.011.12132024-02-01
EKAV101315000DIAGNOcam Vision Full HD1.013.15001.013.15002024-02-01
EKAV101402800MASTERmatic LUX M45 L1.014.02801.014.02802024-02-01
EKAV100071050SONICflex cari-ex 0.8 No. 421.000.7105cari ex 0 8 No 422016-09-26
EKAV100071670SONICflex cari-ex 1.2 No. 431.000.7167cari ex 1 2 No 432016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHEBW2026-02-17
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEBW2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEBW2026-02-13
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.EBW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.EBW2026-01-09
08404535021684ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
08404535021714ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
04589551393381Straumann SGL80MNAKANISHI INC.EBW2026-01-03
04589551393374Straumann Surgical Motor Pro 2NAKANISHI INC.EBW2026-01-03
04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18