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

System, image processing, radiological (LLZ) (7) CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (2) Aligner, sequential (NXC) (2) POSITIONER, TOOTH, PREFORMED (KMY) (2) Mouthguard, prescription (MQC) (2) Powered laser surgical instrument (GEX) (1) Lamp, infrared, therapeutic heating (ILY) (1)

Premarket Exempt

No Yes

Clear

Essiz A+ - D746131201 Catalog Number : 13120

Device Description : Essix A+ Plastic .120 x 120mm PETG Circle 25PK

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC, KMY, NXC, EBG

Prescription Use : Yes

Device Count : 25

Essiz A+ - D746131251 Catalog Number : 13125

Device Description : Essix A+ Plastic .120 x 125mm PETG Circle 25PK

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : EBG, MQC, NXC, KMY

Prescription Use : Yes

Device Count : 25

VISTADENT® OC - D74627310701 Catalog Number : 27-310-70

Device Description : VISTADENT® OC CONSULTANT

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

VISTADENT® OC - D74627310991 Catalog Number : 27-310-99

Device Description : VISTADENT® OC COMPLETE

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

VISTADENT® OC - D7462731099U1 Catalog Number : 27-310-99U

Device Description : VISTADENT® OC COMPLETE UPDATE

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

VISTADENT® OC - D7462731170L1 Catalog Number : 27-311-70L

Device Description : VISTADENT® OC CONSULTANT (LATIN AM)

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

VISTADENT® OC - D7462731199L1 Catalog Number : 27-311-99L

Device Description : VISTADENT® OC COMPLETE LATIN AMERICA

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

VISTADENT® OC - D74627313991 Catalog Number : 27-313-99

Device Description : VISTADENT® OC SUBSCRIPTION EAST

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

VISTADENT® OC - D74627314991 Catalog Number : 27-314-99

Device Description : VISTADENT® OC SUBSCRIPTION LAT AMERICA

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666591011 Catalog Number : 6659101

Device Description : Sculpt I.Q. Laser, USA

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

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