SHOFU DENTAL CORPORATION

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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

POINT, ABRASIVE (EHL) (10)

Premarket Exempt

No Yes

Clear

DURA-GREEN - E23500180 Catalog Number : 0018

Device Description : HP DURA-GREEN IC5

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500190 Catalog Number : 0019

Device Description : HP DURA-GREEN IC6

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500200 Catalog Number : 0020

Device Description : HP DURA-GREEN IC7

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500210 Catalog Number : 0021

Device Description : HP DURA-GREEN IC8

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500220 Catalog Number : 0022

Device Description : HP DURA-GREEN IC9

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500230 Catalog Number : 0023

Device Description : HP DURA-GREEN KN1

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500250 Catalog Number : 0025

Device Description : HP DURA-GREEN KN3

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500260 Catalog Number : 0026

Device Description : HP DURA-GREEN KN4

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500270 Catalog Number : 0027

Device Description : HP DURA-GREEN KN5

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500280 Catalog Number : 0028

Device Description : HP DURA-GREEN KN6

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

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