ORMCO CORPORATION

Address:1937 W. Mission Blvd.,Pomona,CA,91766,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) (6) Implant, Endosseous, Orthodontic (OAT) (4)

Premarket Exempt

Yes No

Clear

Spark - 00889989084825 Catalog Number :

Device Description : Spark 20 / Active - Single Arch

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Spark - 00889989084832 Catalog Number :

Device Description : Spark 20 / Active - Refinement

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Spark - 00889989084849 Catalog Number :

Device Description : Spark 20 / Active - Reorder

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Spark - 00889989084856 Catalog Number :

Device Description : Spark Advanced - Single Arch

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Spark - 00889989084863 Catalog Number :

Device Description : Spark Advanced - Refinement

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Spark - 00889989084870 Catalog Number :

Device Description : Spark Advanced - Reorder

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

VECTOR TAS - 10889989000006 Catalog Number :

Device Description : VECTOR TAS INITIATOR Qty 2

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 2

VECTOR TAS - 10889989000013 Catalog Number :

Device Description : VECTOR TAS TISSUE PUNCH Qty 6

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 6

VECTOR TAS - 10889989000044 Catalog Number :

Device Description : VECTOR TAS DRIVER TIP 40MM - Qty 2

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 2

VECTOR TAS - 10889989000051 Catalog Number :

Device Description : VECTOR TAS DRIVER TIP 22MM - Qty 2

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 2

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