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

Activator, Ultraviolet, For Polymerization (EBZ) (9) Cleanser, Root Canal (KJJ) (1)

Premarket Exempt

No Yes

Clear

SPEC 3 - D661600139440 Catalog Number :

Device Description : SPEC 3 LED Australia Plug Type IA

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

SPEC 3 - D661600139450 Catalog Number :

Device Description : SPEC 3 LED Japan Plug Type AJ

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

SPEC 3 - D661600139481 Catalog Number :

Device Description : SPEC 3 LIGHT SHIELD, 8mm

Device Class :

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 20

SPEC 3 - D661600139500 Catalog Number :

Device Description : SPEC 3 Lear Light Guide, 8mm Turbo Tip

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

SPEC 3 - D661600139510 Catalog Number :

Device Description : SPEC 3 Clear Light Guide, 11mm Straight Tip

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

SPEC 3 - D661600139520 Catalog Number :

Device Description : SPEC 3 Battery Module

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

SPEC 3 - D661600139530 Catalog Number :

Device Description : SPEC 3 Charger Base

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

SPEC 3 - D661600139550 Catalog Number :

Device Description : SPEC 3 Power Supply

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

SPEC 3 - D661600139560 Catalog Number :

Device Description : SPEC 3 LED Chinese Plug Type CH

Device Class : 2

Duns Number: 622185718

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

CanalPro - D661600139940 Catalog Number :

Device Description : CanalPro CHX-Ultra 2%, 480 ml

Device Class : U

Duns Number: 622185718

Premarket Exempt : No

Product Code : KJJ

Prescription Use : No

Device Count : 1

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