FDA.reportPublic FDA data

COMFORTdrive System (USA)

Primary DI
EKAV100736560
Brand
COMFORTdrive System (USA)
Company
KaVo Dental GmbH
Model
1.005.5000
Catalog number
System (USA)
Device description
This is a medical device.
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUNIT, OPERATIVE DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080677000COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECEKaltenbach & Voigt GmbH & Co.2008-06-06EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100736560PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Line-powered dental drilling systemAn assembly of devices designed to bore and excavate bones, teeth, and tough tissues during a dental surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the drilling/excavating endpieces (e.g., drill bits, burs, polishing disks). This system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through a control unit. This is a reusable 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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
EKAV100987570Tube Set S6001.009.8757S6002016-09-26
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

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