Dentlight Inc.

Dentlight Inc.

Address:1825 Summit Ave Ste 210,Plano,TX,75074,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) (3) Diagnostic Light, Soft Tissue Detector (NXV) (1) Laser, Dental, Soft Tissue (NVK) (1) Light, Surgical Headlight (EBA) (1) Loupe, Diagnostic/Surgical (FSP) (1)

Premarket Exempt

No Yes

Clear

FUSION Curing Light - 00860179001006 Catalog Number : 7800080

Device Description : FUSION Curing Light

Device Class : 2

Duns Number: 171208585

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Nano Freedom Headlight - 00860179001020 Catalog Number : 8600115

Device Description : Nano Freedom Headlight

Device Class : 1

Duns Number: 171208585

Premarket Exempt : Yes

Product Code : EBA

Prescription Use : No

Device Count : 1

FUSION Plus Curing Light - 00860179001037 Catalog Number : 7820080

Device Description : FUSION Plus Curing Light

Device Class : 2

Duns Number: 171208585

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Ultrafast Diode Laser - 00860179001044 Catalog Number : 7300100

Device Description : Ultrafast Diode Laser

Device Class : 2

Duns Number: 171208585

Premarket Exempt : No

Product Code : NVK

Prescription Use : Yes

Device Count : 1

FUSION Grand Curing Light - 00860179001068 Catalog Number : 7830080

Device Description : FUSION Grand Curing Light

Device Class : 2

Duns Number: 171208585

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

FUSION-DOE Light System - 00860179001075 Catalog Number : 7700512

Device Description : FUSION-DOE Light System

Device Class : 2

Duns Number: 171208585

Premarket Exempt : No

Product Code : NXV

Prescription Use : Yes

Device Count : 1

iZoom Loupes - 00860179001099 Catalog Number : 8500051

Device Description : iZoom Magnification Loupes

Device Class : 1

Duns Number: 171208585

Premarket Exempt : Yes

Product Code : FSP

Prescription Use : No

Device Count : 1

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