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+ - D746100451 Catalog Number : 10045

Device Description : Essix A+ Plastic .040 x 5" PETG Vacuum Square 100PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, NXC, MQC, EBG

Prescription Use : Yes

Device Count : 100

Essix A+ - D74610045501 Catalog Number : 10045-50

Device Description : Essix A+ Plastic .040 x 5" PETG Vacuum Square 50Pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, KMY, EBG, MQC

Prescription Use : Yes

Device Count : 50

Essix A+ - D74610045SH1 Catalog Number : 10045-SH

Device Description : Essix A+ Plastic .040 x 5" PETG Vacuum Square 20PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, KMY, MQC, NXC

Prescription Use : Yes

Device Count : 20

Essix A+ - D746100601 Catalog Number : 10060

Device Description : Essix A+ Plastic .060 x 4.92" Square 50 PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, NXC, EBG, KMY

Prescription Use : Yes

Device Count : 50

Essix A+® - D74610060251 Catalog Number : 10060-25

Device Description : Essix A+® Plastic - .06 in 125mm SQ

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, MQC, EBG, NXC

Prescription Use : Yes

Device Count : 25

Essix A+ - D746100651 Catalog Number : 10065

Device Description : Essix A+ Plastic .060 x 5" Square 50PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, EBG, KMY, NXC

Prescription Use : Yes

Device Count : 50

Essix A+ - D74610065251 Catalog Number : 10065-25

Device Description : Essix A+ Plastic .060 x 5" Square 25 PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, MQC, NXC, KMY

Prescription Use : Yes

Device Count : 25

Essix A+ - D74610065SH1 Catalog Number : 10065-SH

Device Description : Essix A+ Plastic .060 x 5" Square 20PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, NXC, EBG, KMY

Prescription Use : Yes

Device Count : 20

Essix A+ - D746100801 Catalog Number : 10080

Device Description : Essix A+ Plastic .080 x 125 For Sale 50Pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : KMY, MQC, NXC, EBG

Prescription Use : Yes

Device Count : 50

Essix A+ - D746100851 Catalog Number : 10085

Device Description : Essix A+ Plastic .080 x 5" Square 50PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, EBG, NXC, KMY

Prescription Use : Yes

Device Count : 50

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