Phase Ortho, Inc.

Phase Ortho, Inc.

Address:2501 Stanley Gault PKWY,Louisville,KY,40223,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) (4) Maintainer, Space Preformed, Orthodontic (DYT) (4)

Premarket Exempt

No

Clear

Phase Ortho - 00860006274306 Catalog Number :

Device Description : Phase Ortho Clear Aligner

Device Class : 2

Duns Number: 117872038

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Phase Ortho - 00860006274313 Catalog Number :

Device Description : Phase Ortho Retainer

Device Class : 1

Duns Number: 117872038

Premarket Exempt : No

Product Code : DYT

Prescription Use : Yes

Device Count : 1

Smile Shapers - 00860006274320 Catalog Number :

Device Description : Smile Shapers Clear Aligner - Zendura

Device Class : 2

Duns Number: 117872038

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Smile Shapers - 00860006274337 Catalog Number :

Device Description : Smile Shapers Retainer

Device Class : 1

Duns Number: 117872038

Premarket Exempt : No

Product Code : DYT

Prescription Use : Yes

Device Count : 1

Phase Ortho Private Label - 00860006274344 Catalog Number :

Device Description : Phase Ortho Private Label Clear Aligner - Temporary Placeholder

Device Class : 2

Duns Number: 117872038

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Phase Ortho Private Label - 00860006274351 Catalog Number :

Device Description : Phase Ortho Private Label Retainer - Temporary Placeholder

Device Class : 1

Duns Number: 117872038

Premarket Exempt : No

Product Code : DYT

Prescription Use : Yes

Device Count : 1

Tru-Smile - 00860006274368 Catalog Number :

Device Description : Tru-Smile Clear Aligner

Device Class : 2

Duns Number: 117872038

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Tru-Smile - 00860006274375 Catalog Number :

Device Description : Tru-Smile Retainers

Device Class : 1

Duns Number: 117872038

Premarket Exempt : No

Product Code : DYT

Prescription Use : Yes

Device Count : 1

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