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) (7) Denture, plastic, teeth (ELM) (2) Powered laser surgical instrument (GEX) (1)

Premarket Exempt

No Yes

Clear

MTML-Clear Aligner - D746MTMLALSA1 Catalog Number : MTML-AL-SA

Device Description : MTML-Clear Aligner-Single Arch

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

MTML-Clear Aligner - D746MTMLDAR11 Catalog Number : MTML-DAR1

Device Description : MTML-Clear Aligner - Dual Arch First Refinement

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

MTML-Clear Aligner - D746MTMLDAR21 Catalog Number : MTML-DAR2

Device Description : MTML-Clear Aligner - Dual Arch Additional Refinement

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

MTML-Clear Aligner - D746MTMLRP1 Catalog Number : MTML-RP

Device Description : MTML-Clear Aligner Replacement Alignment

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

MTML-Clear Aligner - D746MTMLSAR11 Catalog Number : MTML-SAR1

Device Description : MTML-Clear Aligner - Single Arch First Refinement

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

MTML-Clear Aligner - D746MTMLSAR21 Catalog Number : MTML-SAR2

Device Description : MTML-Clear Aligner - Single Arch Additional Refinement

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Composite - D746PAB1 Catalog Number : PAB

Device Description : Composite aligner button 10pk

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 10

PICASSO - D746PL001PFWRT1 Catalog Number : PL001-PFW-RT

Device Description : PICASSO LITE 2.5 WATT DIODE Laser Package

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Posterior Lower Pontic - D746PLMOG1 Catalog Number : PLMO-G

Device Description : Posterior Lower Pontic Set - Gray

Device Class :

Duns Number: 801157132

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 8

Posterior Lower Pontic - D746PLMOW1 Catalog Number : PLMO-W

Device Description : Posterior Lower Pontic Set - White

Device Class :

Duns Number: 801157132

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 8

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