SWIFT HEALTH SYSTEMS INC.

Address:5 Goodyear,Irvine,CA,92618,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

Orthodontic Software (PNN) (7) Instruments, Dental Hand (DZN) (2)

Premarket Exempt

No Yes

Clear

Inbrace Teeth Straightening System - 00850018135009 Catalog Number : 8101

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Inbrace Teeth Straightening System - 00850018135016 Catalog Number : 8111

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

InBrace Teeth Straightening System (Gen 2.0) - 00850018135030 Catalog Number : 85002

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

InBrace Teeth Straightening System (Gen 2.0) - 00850018135047 Catalog Number : 85000

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

InBrace Teeth Straightening System (Gen 2.0) - 00850018135054 Catalog Number : 85003

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Inbrace Teeth Straightening System - 00850018135122 Catalog Number : 8131

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Inbrace Teeth Straightening System - 00850018135139 Catalog Number : 8121

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Smartwire InGager - 00850018135399 Catalog Number : 85001

Device Description : An orthodontic reusable instrument intended for use with the InBrace Teeth Strai An orthodontic reusable instrument intended for use with the InBrace Teeth Straightening System (Gen 2.0) to insert, ligate and remove Smartwires from brackets.

Device Class : 1

Duns Number: 884398210

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

InBrace Starter Kit - 10850018135396 Catalog Number : 83000

Device Description : This device is a kit containing 3 Smartwire InGager instruments and spare bracke This device is a kit containing 3 Smartwire InGager instruments and spare brackets for use with InBrace Teeth Straightening System (Gen 2.0)

Device Class : 1

Duns Number: 884398210

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

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