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

Denture, plastic, teeth (ELM) (4) Mouthguard, prescription (MQC) (3) Powered laser surgical instrument (GEX) (3) Aligner, sequential (NXC) (1) CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (1) POSITIONER, TOOTH, PREFORMED (KMY) (1)

Premarket Exempt

No Yes

Clear

Posterior Lower Pontic - D746PLMOY1 Catalog Number : PLMO-Y

Device Description : Posterior Lower Pontic Set - Yellow

Device Class :

Duns Number: 801157132

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 8

Picasso - D746PLPLUS1 Catalog Number : PLPLUS

Device Description : Picasso Lite Plus Package with multi-tip handpiece

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Picasso - D746PPLUS1 Catalog Number : PPLUS

Device Description : Picasso Plus Package with multi-tip handpiece

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PICASSO - D746PS001PFWRT1 Catalog Number : PS001-PFW-RT

Device Description : PICASSO 7.0 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 - D746PUMOG1 Catalog Number : PUMO-G

Device Description : Posterior Upper Pontic Set - Gray Set of 8

Device Class :

Duns Number: 801157132

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 8

Posterior Lower Pontic - D746PUMOW1 Catalog Number : PUMO-W

Device Description : Posterior Upper Pontic Set - White Set of 8

Device Class :

Duns Number: 801157132

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 8

Posterior Lower Pontic - D746PUMOY1 Catalog Number : PUMO-Y

Device Description : Posterior Upper Pontic Set - Yellow Set of 8

Device Class :

Duns Number: 801157132

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 8

RMbond Thermoform - D746RMUFS040X100S1 Catalog Number : RMUFS040X100S

Device Description : J00376 - RMbond thermoform sheets .040" 100PK SQ

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 100

RMbond Thermoform - D746RMUFS040X10S1 Catalog Number : RMUFS040X10S

Device Description : J00375 - RMbond Thermoform sheets .040". 10PK SQ

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 10

SULLIVAN - D746S2BS1 Catalog Number : S2-BS

Device Description : SULLIVAN BRUXISM SPLINT CLEAR EACH

Device Class : 1

Duns Number: 801157132

Premarket Exempt : No

Product Code : KMY, NXC, MQC, EBG

Prescription Use : Yes

Device Count : 1

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