COLTENE/WHALEDENT INC

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

Bur, Dental (EJL) (5) Handpiece, Direct Drive, Ac-Powered (EKX) (4) Dam, Rubber (EIE) (1)

Premarket Exempt

No Yes

Clear

Alpen - D611X856TC0141 Catalog Number :

Device Description : ROUND END TAPER TC

Device Class :

Duns Number: 622185718

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 25

Alpen - D61R6000351 Catalog Number :

Device Description : ALPEN CARBIDE 35 HP 10PK

Device Class :

Duns Number: 622185718

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 10

HYGENIC - D660H09945C1 Catalog Number : H09945C

Device Description : HYG. FLEXI DAM NON-LATEX PURPLE

Device Class : 1

Duns Number: 622185718

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : Yes

Device Count : 1

Clinic Pack - D661100057C1 Catalog Number :

Device Description : FG57 BUR 100PK

Device Class : 1

Duns Number: 622185718

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 100

Alpen - D661100057X1 Catalog Number :

Device Description : FG57 1MM STRAIGHT BUR 10PK

Device Class : 1

Duns Number: 622185718

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 10

Strauss - D661100057XXV1 Catalog Number :

Device Description : FG57 1MM STRAIGHT BUR 25PK

Device Class : 1

Duns Number: 622185718

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 25

CanalPro - D661600110370 Catalog Number :

Device Description : CL Handpiece

Device Class : 1

Duns Number: 622185718

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

CanalPro - D661600110380 Catalog Number :

Device Description : CL Charger 120-140V

Device Class : 1

Duns Number: 622185718

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

CanalPro - D661600110390 Catalog Number :

Device Description : CL Contra-Angle 16:1

Device Class : 1

Duns Number: 622185718

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

CanalPro - D661600110410 Catalog Number :

Device Description : CL Contra-Angle Gear

Device Class : 1

Duns Number: 622185718

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

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