COLTENE/WHALEDENT INC

Address:701 Technology Drive,Canonsburg,PA,15317,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 - D661600142470 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 - D661600142480 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 - D661600142490 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 - D661600142500 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 - D661600142510 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 - D661600142520 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 - D661600142530 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 - D661600142540 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 - D661600142550 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 - D661600142560 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

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