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 - D661600142810 Catalog Number :

Device Description : Suvi Scaler Tip - PE40

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142820 Catalog Number :

Device Description : Suvi Scaler Tip - PE40L

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142830 Catalog Number :

Device Description : Suvi Scaler Tip - PE40R

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142840 Catalog Number :

Device Description : Suvi Scaler Tip - PE40H

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142850 Catalog Number :

Device Description : Suvi Scaler Tip - PE41PS

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142860 Catalog Number :

Device Description : Suvi Scaler Tip - IM1

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142870 Catalog Number :

Device Description : Suvi Scaler Tip - IM2

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142920 Catalog Number :

Device Description : Suvi Scaler Tip - EN1

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143030 Catalog Number :

Device Description : Suvi Scaler Tip - EN14

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600143040 Catalog Number :

Device Description : Suvi Scaler Tip - EN15

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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