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) (8) Lamp, infrared, therapeutic heating (ILY) (2) Powered laser surgical instrument (GEX) (2)

Premarket Exempt

No Yes

Clear

Sculpt I.Q. - D74666595561 Catalog Number : 6659556

Device Description : Wireless Foot Control

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : ILY, GEX

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666614201 Catalog Number : 6661420

Device Description : Upgrade Package, 660nm wavelength

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746825101 Catalog Number : 82510

Device Description : Thermoplier® Undercut Enhancer Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746825201 Catalog Number : 82520

Device Description : Thermoplier® Maxillary Tooth Moving Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746825301 Catalog Number : 82530

Device Description : Thermoplier® Mandibular Tooth Moving Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D7468253B1 Catalog Number : 8253B

Device Description : Thermoplier® Max. & Mandi Pliers Combo

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746825401 Catalog Number : 82540

Device Description : Thermoplier® Bite Plane Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746825501 Catalog Number : 82550

Device Description : Thermoplier® Elastic Hook-Forming Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746825601 Catalog Number : 82560

Device Description : Thermoplier® Micro-Ramp Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Thermoplier® - D746825701 Catalog Number : 82570

Device Description : Thermoplier® Elastic Slot Forming Pliers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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