COLTENE/WHALEDENT INC

Address:235 Ascot Pkwy,CUYAHOGA FALLS,OH,44223,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Scaler, Ultrasonic (ELC) (10)

Premarket Exempt

Yes No

Clear

BioSonic - D661600143050 Catalog Number :

Device Description : Suvi Scaler Tip - EN9

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143060 Catalog Number :

Device Description : Suvi Scaler Tip - EN10

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143070 Catalog Number :

Device Description : Suvi Scaler Tip - EN11

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143080 Catalog Number :

Device Description : Suvi Scaler Tip - FH1

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143090 Catalog Number :

Device Description : Suvi Scaler Tip - FH2

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143100 Catalog Number :

Device Description : Suvi Scaler Tip - FH3

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143110 Catalog Number :

Device Description : Suvi Scaler Tip - IH1

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143120 Catalog Number :

Device Description : Suvi Scaler Tip - IH2

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143210 Catalog Number :

Device Description : Suvi Scaler Tip - SP34

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143220 Catalog Number :

Device Description : Suvi Scaler Tip - SP34S

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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