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 - D661600142710 Catalog Number :

Device Description : Suvi Scaler Tip - PE37R

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142720 Catalog Number :

Device Description : Suvi Scaler Tip - 41P

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142730 Catalog Number :

Device Description : Suvi Scaler Tip - 41AF

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142740 Catalog Number :

Device Description : Suvi Scaler Tip - 41PF

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142750 Catalog Number :

Device Description : Suvi Scaler Tip - PE33

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142760 Catalog Number :

Device Description : Suvi Scaler Tip - PE33L

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142770 Catalog Number :

Device Description : Suvi Scaler Tip - 33R

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142780 Catalog Number :

Device Description : Suvi Scaler Tip - PE38

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142790 Catalog Number :

Device Description : Suvi Scaler Tip - PE38L

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

BioSonic - D661600142800 Catalog Number :

Device Description : Suvi Scaler Tip - PE38R

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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