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 - D661600142590 Catalog Number :

Device Description : Suvi Medicament Feeder

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142600 Catalog Number :

Device Description : Suvi Polisher Powder Feeder

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142610 Catalog Number :

Device Description : Suvi Handpiece - Piezo Scaler

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142620 Catalog Number :

Device Description : Suvi Air Polisher Handpiece

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142650 Catalog Number :

Device Description : Suvi Scaler Tip - PE31

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142660 Catalog Number :

Device Description : Suvi Scaler Tip - PE32

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142670 Catalog Number :

Device Description : Suvi Scaler Tip - PE39

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142680 Catalog Number :

Device Description : Suvi Scaler Tip - PE41A

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142690 Catalog Number :

Device Description : Suvi Scaler Tip - PE37

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142700 Catalog Number :

Device Description : Suvi Scaler Tip - PE37L

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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