SHOFU DENTAL CORPORATION

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) (6) Material, tooth shade, resin (EBF) (4)

Premarket Exempt

No Yes

Clear

SUPER-SNAP - 04548162235367 Catalog Number : 0500

Device Description : Super-Snap Rainbow Technique Kit

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

SUPER-SNAP - 04548162235381 Catalog Number : L525

Device Description : SUPER SNAP POLYSTRIPS, BK/VT 1

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

SUPER-SNAP - 04548162235398 Catalog Number : L526

Device Description : SUPER SNAP POLYSTRIPS, GN/RED

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

BEAUTIFIL KIDS SA - 04548162310224 Catalog Number : Y1011

Device Description : BEAUTIFIL KIDS SA A2 2.2g

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

BEAUTIFIL KIDS SA - 04548162310231 Catalog Number : Y1012

Device Description : BEAUTIFIL KIDS SA B1 2.2g

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

BEAUTIFIL KIDS SA - 04548162310255 Catalog Number : Y1014

Device Description : BEAUTIFIL KIDS SA A1 1.0g

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

BEAUTIFIL KIDS SA - 04548162310262 Catalog Number : Y1015

Device Description : BEAUTIFIL KIDS SA A2 1.0g

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500020 Catalog Number : 0002

Device Description : HP DURA-GREEN CN1

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500060 Catalog Number : 0006

Device Description : HP DURA-GREEN CY2

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

DURA-GREEN - E23500070 Catalog Number : 0007

Device Description : HP DURA-GREEN CY3

Device Class : 1

Duns Number: 054618202

Premarket Exempt : Yes

Product Code : EHL

Prescription Use : Yes

Device Count : 1

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