DENTRONIX INC

DENTRONIX INC

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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

Sterilizer, Dry Heat (KMH) (8) Activator, Ultraviolet, For Polymerization (EBZ) (2)

Premarket Exempt

No

Clear

Dentronix - D661600139470 Catalog Number :

Device Description : Dentronix LED 3000 Plug Type A

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

Dentronix - D661600139540 Catalog Number :

Device Description : LED 3000 Charger Base

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : EBZ

Prescription Use : No

Device Count : 1

Dentronix - D661D5000SHT0 Catalog Number :

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

Dentronix - D661D5000ST0 Catalog Number :

Device Description : Horizontal Tray

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

Dentronix - D661D7000C0 Catalog Number :

Device Description : Standard Combo Rack

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

Dentronix - D661D7000CL0 Catalog Number :

Device Description : Long Handle Combo Rack

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

Dentronix - D661D7000F0 Catalog Number :

Device Description : Replacement HEPA Filter

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

Dentronix - D661D7000MS0 Catalog Number :

Device Description : Vertical Plier Rack - Mini

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

Dentronix - D661D7000SILVER0 Catalog Number :

Device Description : Vertical Plier Rack

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

Dentronix - D661D7107010 Catalog Number :

Device Description : Accessory Kit for DDS7000

Device Class : 2

Duns Number: 085690428

Premarket Exempt : No

Product Code : KMH

Prescription Use : No

Device Count : 1

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