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

MATERIAL, TOOTH SHADE, RESIN (EBF) (10)

Premarket Exempt

No Yes

Clear

Beautifil Flow Plus X - E235YN23150 Catalog Number : YN2315

Device Description : BEAUTIFIL FLOW PLUS X F00BW

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23200 Catalog Number : YN2320

Device Description : BEAUTIFIL FLOW PLUS X F03SA0.5

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23210 Catalog Number : YN2321

Device Description : BEAUTIFIL FLOW PLUS X F03A1

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23220 Catalog Number : YN2322

Device Description : BEAUTIFIL FLOW PLUS X F03A2

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23230 Catalog Number : YN2323

Device Description : BEAUTIFIL FLOW PLUS X F03A3

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23240 Catalog Number : YN2324

Device Description : BEAUTIFIL FLOW PLUS X F03A3.5

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23250 Catalog Number : YN2325

Device Description : BEAUTIFIL FLOW PLUS X F03A4

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23260 Catalog Number : YN2326

Device Description : BEAUTIFIL FLOW PLUS X F03B1

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23270 Catalog Number : YN2327

Device Description : BEAUTIFIL FLOW PLUS X F03B2

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Beautifil Flow Plus X - E235YN23280 Catalog Number : YN2328

Device Description : BEAUTIFIL FLOW PLUS X F03C2

Device Class : 2

Duns Number: 054618202

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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