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 - E23500080 Catalog Number : 0008

Device Description : HP DURA-GREEN CY4

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500090 Catalog Number : 0009

Device Description : HP DURA-GREEN FL1

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500100 Catalog Number : 0010

Device Description : HP DURA-GREEN FL2

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500110 Catalog Number : 0011

Device Description : HP DURA-GREEN FL3

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500120 Catalog Number : 0012

Device Description : HP DURA-GREEN FL4

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500130 Catalog Number : 0013

Device Description : HP DURA-GREEN FL5

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500140 Catalog Number : 0014

Device Description : HP DURA-GREEN IC1

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500150 Catalog Number : 0015

Device Description : HP DURA-GREEN IC2

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500160 Catalog Number : 0016

Device Description : HP DURA-GREEN IC3

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500170 Catalog Number : 0017

Device Description : HP DURA-GREEN IC4

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

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