AURADONICS INC.

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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

Band, Elastic, Orthodontic (ECI) (10)

Premarket Exempt

Yes

Clear

AURADONICS - 00810033830303 Catalog Number :

Device Description : ELAST-O-TIES - SPARKLE RED, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830310 Catalog Number :

Device Description : ELAST-O-TIES - SPARKLE BLUE, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830327 Catalog Number :

Device Description : ELAST-O-TIES - BABY PINK, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830334 Catalog Number :

Device Description : ELAST-O-TIES - LILAC, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830341 Catalog Number :

Device Description : ELAST-O-TIES - PEARL, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830358 Catalog Number :

Device Description : ELAST-O-TIES - CORAL, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830365 Catalog Number :

Device Description : BITE-SIZE TIES - GRAY, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830372 Catalog Number :

Device Description : BITE-SIZE TIES - MULTIPAK, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830389 Catalog Number :

Device Description : BITE-SIZE TIES - CLEAR, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830396 Catalog Number :

Device Description : VERSA LIG TIE BULK - CLEAR, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

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