FDA.reportPublic FDA data

PROPHYflex 4 Wave

Primary DI
EKAV300280000
Brand
PROPHYflex 4 Wave
Company
KaVo Dental GmbH
Model
3.002.8000
Catalog number
PROPHYflex 4 Wave
Device description
This is a medical device.
Published
2020-03-24
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
EFBHandpiece, air-powered, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181110000PROPHYflex 4Kaltenbach & Voigt GmbH2019-04-10EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV300280000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive air jet system handpieceA hand-held, dental device that is a component of a dental abrasive air jet system and which is used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. This device is connected to the control unit that regulates the sources of pressurized air and temperate water. The abrasive, typically in the form of a powder that, depending upon the design of the delivery method, can be contained within a receptacle in this device or a receptacle within the control unit, is mixed with the air and water as this passes through. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
333710619
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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EKAV100059570RONDOflex powder 27m (1000g)1.000.5957NA2016-09-26
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EKAV101375400SURGmatic S201 L Pro1.013.75401.013.75402020-01-24
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EKAV101112130DIAGNOcam Vision Full HD1.011.12131.011.12132024-02-01
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EKAV100071050SONICflex cari-ex 0.8 No. 421.000.7105cari ex 0 8 No 422016-09-26

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