FDA.reportPublic FDA data

Refill PROPHYflex perio tip

Primary DI
EKAV101002870
Brand
Refill PROPHYflex perio tip
Company
KaVo Dental GmbH
Model
1.010.0287
Catalog number
1.010.0287
Device description
PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, implants and crowns.
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
EKAV101002870PrimaryHIBCC0

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
Handling Environment Temperature-50 Degrees Celsius80 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
333710619
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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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
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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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