Home GUDID EKAV100620210 SONICflex cem Tip No. 12 (A)
Primary DI EKAV100620210
Brand SONICflex cem Tip No. 12 (A)
Company KaVo Dental GmbH
Model 1.006.2021
Catalog number cem Tip No 12 A
Device description This is a medical device.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 EKAV100620210 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 Lot or batch 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
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