Refill PROPHYflex perio tip 1.010.0287

GUDID EKAV101002870

PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, implants and crowns.

KaVo Dental GmbH

Dental abrasive air jet system handpiece
Primary Device IDEKAV101002870
NIH Device Record Keye349f736-3362-4a77-b942-3a4a4e764395
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefill PROPHYflex perio tip
Version Model Number1.010.0287
Catalog Number1.010.0287
Company DUNS333710619
Company NameKaVo Dental GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 80 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV101002870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


[EKAV101002870]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-25
Device Publish Date2023-04-17

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EKAV101002870 - Refill PROPHYflex perio tip2023-04-25PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, implants and crowns.
EKAV101002870 - Refill PROPHYflex perio tip2023-04-25 PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, i
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