RAINTREE ESSIX 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

Aligner, sequential (NXC) (10)

Premarket Exempt

No Yes

Clear

Thermoplier® - D746825901 Catalog Number : 82590

Device Description : Thermoplier® Bubble Forming Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Bonding Buttons - D746826041 Catalog Number : 82604

Device Description : Bonding Buttons - Pack of 10

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 10

Thermoplier® - D746826101 Catalog Number : 82610

Device Description : Thermoplier® Large Circle Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746826201 Catalog Number : 82620

Device Description : Thermoplier® Small Circle Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746826301 Catalog Number : 82630

Device Description : Thermoplier® Mesial Distal Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

H.I.T. - D746827201 Catalog Number : 82720

Device Description : H.I.T.® - Insertion Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

H.I.T. - D746827401 Catalog Number : 82740

Device Description : H.I.T.® - Punch Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Gingival Window Pliers - D746827GW1 Catalog Number : 827GW

Device Description : Gingival Window Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

H.I.T. - D746827HC1 Catalog Number : 827HC

Device Description : H.I.T.® - Kit of 2 Pliers

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 2

Incisal Window Pliers - D746827IW1 Catalog Number : 827IW

Device Description : Incisal Window Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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