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 - D661600142370 Catalog Number :

Device Description : SUVI Premier Ultrasonic Scaler

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142380 Catalog Number :

Device Description : SUVI Premier Plus Ultrasonic Scaler

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142390 Catalog Number :

Device Description : SUVI Elite Ultrasonic Scaler/Polisher

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142400 Catalog Number :

Device Description : SUVI Elite Plus Ultrasonic Scaler/Polisher

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142410 Catalog Number :

Device Description : SUVI Premier Ultrasonic Scaler

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142420 Catalog Number :

Device Description : SUVI Premier Plus Ultrasonic Scaler

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142430 Catalog Number :

Device Description : SUVI Elite Ultrasonic Scaler/Polisher

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142440 Catalog Number :

Device Description : SUVI Elite Plus Ultrasonic Scaler/Polisher

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142450 Catalog Number :

Device Description : SUVI Premier Ultrasonic Scaler

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142460 Catalog Number :

Device Description : SUVI Premier Plus ultrasonic Scaler

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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