STRAIGHT SMILE LLC

Address:18120 S Broadway,Gardena,CA,90248,US

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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

Aligner, Sequential (NXC) (3) Positioner, Tooth, Preformed (KMY) (1)

Premarket Exempt

Yes No

Clear

Byte Day Alignes - 00850017524163 Catalog Number : PRS-0063

Device Description : Sequential Aligners

Device Class : 2

Duns Number: 081010579

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Byte Night Aligners - 00850017524170 Catalog Number : PRS-0063

Device Description : Sequential Aligners

Device Class : 2

Duns Number: 081010579

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Byte Retainer - 00850017524187 Catalog Number : PRS-0063

Device Description : Dental retainer

Device Class : 1

Duns Number: 081010579

Premarket Exempt : Yes

Product Code : KMY

Prescription Use : Yes

Device Count : 1

Byte Aligner System - 00860000506007 Catalog Number : PRS-0063

Device Description : Sequential Aligners

Device Class : 2

Duns Number: 081010579

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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