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 ACE - D7461A4781 Catalog Number : 1A478

Device Description : Essix ACE 040 x 4.875" PCTG Vacuum Square 100pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, MQC, NXC, EBG

Prescription Use : Yes

Device Count : 100

Essix ACE® - D7461A478501 Catalog Number : 1A478-50

Device Description : Essix ACE® Plastic - .040in 125mm Square

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, EBG, KMY, MQC

Prescription Use : Yes

Device Count : 50

Essix ACE - D7461AH201 Catalog Number : 1AH20

Device Description : Essix ACE .035" 120mm Circle 100/PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, NXC, KMY, MQC

Prescription Use : Yes

Device Count : 100

Essix ACE® - D7461AH20501 Catalog Number : 1AH20-50

Device Description : Essix ACE® Plastic - .035in 120mm Circle

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, NXC, KMY, EBG

Prescription Use : Yes

Device Count : 50

Essix ACE® - D7461AH251 Catalog Number : 1AH25

Device Description : Essix ACE Plastic 035 x 125mm Circle 100pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, KMY, EBG, NXC

Prescription Use : Yes

Device Count : 100

Essix ACE® - D7461AH25501 Catalog Number : 1AH25-50

Device Description : Essix ACE® Plastic - .035in 125mm Circle

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, EBG, KMY, MQC

Prescription Use : Yes

Device Count : 50

Essix ACE® - D7461AH25SH1 Catalog Number : 1AH25-SH

Device Description : Essix ACE® Plastic - .035in 125mm Circle Shinwon

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, KMY, MQC, EBG

Prescription Use : Yes

Device Count : 20

Essix ACE® - D7461AH3471 Catalog Number : 1AH347

Device Description : Essix ACE Plastic - .035in 125mm Square 100pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, EBG, KMY, NXC

Prescription Use : Yes

Device Count : 100

Essix ACE® - D7461AH347501 Catalog Number : 1AH347-50

Device Description : Essix ACE® Plastic - .035in 125mm Square

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, NXC, KMY, MQC

Prescription Use : Yes

Device Count : 20

Essix ACE® - D7461AH501 Catalog Number : 1AH50

Device Description : Essix ACE Plastic .035 x Vacuum Square 100pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, EBG, MQC, NXC

Prescription Use : Yes

Device Count : 100

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