DENTSPLY SIRONA ORTHODONTICS INC.

Address:7290 26th Court East,Sarasota,FL,34243,US

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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) CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (10) Mouthguard, prescription (MQC) (10) POSITIONER, TOOTH, PREFORMED (KMY) (10)

Premarket Exempt

No Yes

Clear

Essix A+ - D746110201 Catalog Number : 11020

Device Description : Essix A+ Plastic .020 x 125mm circle 100PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, EBG, MQC, KMY

Prescription Use : Yes

Device Count : 100

Essix A+® - D74611020501 Catalog Number : 11020-50

Device Description : Essix A+® Plastic -.020in 125mm CIR

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, NXC, KMY, MQC

Prescription Use : Yes

Device Count : 50

Essix A+ - D74611020SH1 Catalog Number : 11020-SH

Device Description : Essix A+ Plastic .020 x 125mm circle 20PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, MQC, KMY, EBG

Prescription Use : Yes

Device Count : 20

Essix A+ - D746110211 Catalog Number : 11021

Device Description : Essix A+ plastic .020 x 120mm circle 100PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, MQC, NXC, EBG

Prescription Use : Yes

Device Count : 100

Essix A+ - D746110301 Catalog Number : 11030

Device Description : Essix A+ Plastic .030 x 125mm Circle 100PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, EBG, NXC, MQC

Prescription Use : Yes

Device Count : 100

Essix A+ - D74611030SH1 Catalog Number : 11030-SH

Device Description : Essix A+ Plastic .030 x 125mm Circle 20PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, MQC, EBG, NXC

Prescription Use : Yes

Device Count : 20

Essix A+ - D746110311 Catalog Number : 11031

Device Description : Essix A+ Plastic .030 x 120mm PETG Vacuum Circles 100PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, KMY, EBG, MQC

Prescription Use : Yes

Device Count : 100

Essix A+ - D746110401 Catalog Number : 11040

Device Description : Essix A+ .040 x 125mm Circle (100PK)

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, MQC, NXC, KMY

Prescription Use : Yes

Device Count : 100

Essix A+® - D74611040501 Catalog Number : 11040-50

Device Description : Essix A+® Plastic - .040in 125mm CIR

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, KMY, MQC, EBG

Prescription Use : Yes

Device Count : 50

Essix A+ - D74611040SH1 Catalog Number : 11040-SH

Device Description : Essix A+ .040 x 125mm Circle 20PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, EBG, MQC, KMY

Prescription Use : Yes

Device Count : 20

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