DENTALEZ, 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

Diagnostic Light, Soft Tissue Detector (NXV) (2) Dental Barriers And Sleeves (PEM) (1) Sunglasses (Non-Prescription Including Photosensitive) (HQY) (1)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D702RT3003870 Catalog Number :

Device Description : INTL Dealer Demo Kit

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : NXV

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D702RT3003900 Catalog Number :

Device Description : Identafi System, European

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : NXV

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D702RT3004150 Catalog Number :

Device Description : Disposable Plastic Barrier PKGD 100 BOX Identafi Wand

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : PEM

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D702RT3220000 Catalog Number :

Device Description : Script/Magnification Eyewear, Black Frame, Rose Lens

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : Yes

Device Count : 1

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