ORTHOFX

ORTHOFX

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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

Maintainer, Space Preformed, Orthodontic (DYT) (4) Aligner, Sequential (NXC) (3) Tray, Impression, Preformed (EHY) (2) Material, Impression (ELW) (1) Wax, Dental, Intraoral (EGD) (1)

Premarket Exempt

No Yes

Clear

OrthoFX - 00860003321706 Catalog Number :

Device Description : Updated UDI submission for Zendura material aligners.

Device Class : 2

Duns Number: 033755180

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

OrthoFX - 00860003321713 Catalog Number :

Device Description : OrthoFX Retainer

Device Class : 1

Duns Number: 033755180

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : Yes

Device Count : 1

Glo Science - 00860003321720 Catalog Number :

Device Description : Over the counter teeth whitening gel

Device Class :

Duns Number: 033755180

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

OrthoFX - 00860003321737 Catalog Number :

Device Description : OrthoFX Retainer

Device Class : 1

Duns Number: 033755180

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : Yes

Device Count : 1

OrthoFX Home Impression Kit - 00860003321744 Catalog Number :

Device Description : Revise Home Impression Kit UDI (PVS version)

Device Class : 1

Duns Number: 033755180

Premarket Exempt : No

Product Code : ELW, EHY

Prescription Use : Yes

Device Count : 1

OrthoFX Rescue Aligner - 00860003321751 Catalog Number :

Device Description : OrthoFX Rescue aligner. Specialized purpose of bringing off track treatment back on track.

Device Class : 2

Duns Number: 033755180

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

OrthoFX - 00860003321765 Catalog Number :

Device Description : Tetra Bright AlignersTetra Bright Aligners appears to whiten teeth while correct Tetra Bright AlignersTetra Bright Aligners appears to whiten teeth while correcting dentition.

Device Class : 1

Duns Number: 033755180

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : Yes

Device Count : 1

OrthoFX - 00860003321775 Catalog Number :

Device Description : Boil and Bite Home Impression Kit.

Device Class : 1

Duns Number: 033755180

Premarket Exempt : Yes

Product Code : EHY, EGD

Prescription Use : No

Device Count : 1

OrthoFX - 18600033217063 Catalog Number :

Device Class : 2

Duns Number: 033755180

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

OrthoFX - 18600033217131 Catalog Number :

Device Class : 1

Duns Number: 033755180

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : Yes

Device Count : 1

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