DENTSPLY SIRONA ORTHODONTICS INC.

Address:2350 CAMPBELL CREEK BLVD.,RICHARDSON,TX,75082,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 - D7461A350501 Catalog Number : 1A350-50

Device Description : Essix ACE .030 x 5" PCTG Square 50pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, EBG, MQC, KMY

Prescription Use : Yes

Device Count : 50

Essix ACE - D7461A350SH1 Catalog Number : 1A350-SH

Device Description : Essix ACE 030 x 5" PCTG Vacuum Square 20PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, EBG, KMY, MQC

Prescription Use : Yes

Device Count : 20

Essix ACE - D7461A4201 Catalog Number : 1A420

Device Description : Essix ACE 040 x 120mm PCTG Vacuum Circle 100pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, EBG, KMY, NXC

Prescription Use : Yes

Device Count : 100

Essix ACE - D7461A420501 Catalog Number : 1A420-50

Device Description : Essix ACE .040 x 120mm PCTG Circle 50pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, MQC, KMY, NXC

Prescription Use : Yes

Device Count : 50

Essix ACE - D7461A4251 Catalog Number : 1A425

Device Description : Essix ACE 040 x 125mm PCTG Vacuum Circle 100pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, EBG, KMY, NXC

Prescription Use : Yes

Device Count : 100

Essix ACE - D7461A425501 Catalog Number : 1A425-50

Device Description : Essix ACE .040 x 125mm PCTG Circle 50pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : EBG, KMY, NXC, MQC

Prescription Use : Yes

Device Count : 50

Essix ACE - D7461A425SH1 Catalog Number : 1A425-SH

Device Description : Essix ACE 040 x 125mm PCTG Vacuum Circle 20pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, NXC, EBG, KMY

Prescription Use : Yes

Device Count : 20

Essix ACE - D7461A4501 Catalog Number : 1A450

Device Description : Essix ACE 040 x 5" x 5" PCTG Vacuum Square 100pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : NXC, EBG, KMY, MQC

Prescription Use : Yes

Device Count : 100

Essix ACE - D7461A450501 Catalog Number : 1A450-50

Device Description : Essix ACE .040 x 5" PCTG Square 50pk

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, KMY, EBG, NXC

Prescription Use : Yes

Device Count : 50

Essix ACE - D7461A450SH1 Catalog Number : 1A450-SH

Device Description : Essix ACE 040 x 5" PCTG Vacuum Square 20PK

Device Class :

Duns Number: 116903307

Premarket Exempt : No

Product Code : MQC, EBG, KMY, NXC

Prescription Use : Yes

Device Count : 20

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