Home GUDID EKAV100716070 SONICflex 2008 L (Set)
Primary DI EKAV100716070
Brand SONICflex 2008 L (Set)
Company KaVo Dental GmbH
Model 1.007.1607
Catalog number 2008 L Set
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 Product Codes# Code, Name table Code Name ELC Scaler, ultrasonic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ELC Scaler, Ultrasonic Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EKAV100716070 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Ultrasonic dental scaling/debridement system An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -20 Degrees Celsius 70 Degrees Celsius
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 333710619 Device count 1 DM exempt true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published EKAV057405000 DIAGNOdent 2095 0.574.0500 2095 2016-09-26 EKAV100059540 RONDOflex powder 50m (75g) 1.000.5954 NA 2016-09-26 EKAV100059550 RONDOflex powder 27m (75g) 1.000.5955 NA 2016-09-26 EKAV100059560 RONDOflex powder 50m (1000g) 1.000.5956 NA 2016-09-26 EKAV100059570 RONDOflex powder 27m (1000g) 1.000.5957 NA 2016-09-26 EKAV100720000 SonicFill Handpiece 34920 1.007.2000 34920 2016-09-26 EKAV100620270 SONICflex implant set A 1.006.2027 1.006.2027 2025-01-31 EKAV100863840 SONICflex prep crown round no. 97 A 1.008.6384 1.008.6384 2025-01-31 EKAV100863860 SONICflex prep crown plain no. 98 A 1.008.6386 1.008.6386 2025-01-31 EKAV101537000 DIAGNOcam Vision Full HD 1.015.3700 1.015.3700 2024-12-03 EKAV100835000 EXPERTsurg LUX 1.008.3500 1.008.3500 2016-09-26 EKAV100987570 Tube Set S600 1.009.8757 S600 2016-09-26 EKAV100880000 INTRA LUX S600 LED 1.008.8000 1.008.8000 2016-09-26 EKAV100910100 SURGmatic S11 L 1.009.1010 1.009.1010 2016-09-26 EKAV101375400 SURGmatic S201 L Pro 1.013.7540 1.013.7540 2020-01-24 EKAV101375410 SURGmatic S201 XL Pro 1.013.7541 1.013.7541 2020-01-24 EKAV101112130 DIAGNOcam Vision Full HD 1.011.1213 1.011.1213 2024-02-01 EKAV101315000 DIAGNOcam Vision Full HD 1.013.1500 1.013.1500 2024-02-01 EKAV101402800 MASTERmatic LUX M45 L 1.014.0280 1.014.0280 2024-02-01 EKAV100071050 SONICflex cari-ex 0.8 No. 42 1.000.7105 cari ex 0 8 No 42 2016-09-26
Other Devices Sharing Product Codes# 
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