ORMCO CORPORATION

Address:200 S. Kraemer Blvd,Brea,CA,92821,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

Bracket, Ceramic, Orthodontic (NJM) (7) Aligner, Sequential (NXC) (3)

Premarket Exempt

Yes No

Clear

Symetri Clear - 00889989084719 Catalog Number :

Device Description : L5R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018-17/2/0 W/HOOK

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Symetri Clear - 00889989084726 Catalog Number :

Device Description : L5L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018-17/2/0 W/HOOK

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Symetri Clear - 00889989084733 Catalog Number :

Device Description : SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UP/LO 5-5 WITH HOOKS 3-4-5 .018

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Symetri Clear - 00889989084740 Catalog Number :

Device Description : SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UP/LO 3-3 WITH HOOKS ON 3 .018

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Symetri Clear - 00889989084757 Catalog Number :

Device Description : SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UPPER 3-3 WITH HOOKS ON 3 .018

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Symetri Clear - 00889989084771 Catalog Number :

Device Description : SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UPPER 5-5 WITH HOOKS ON 3 .018

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Symetri Clear - 00889989084788 Catalog Number :

Device Description : SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UPPER 5-5 WITH HOOKS 3-4-5 .018

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Spark - 00889989084795 Catalog Number :

Device Description : Spark 10 / Apt - Single Arch

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Spark - 00889989084801 Catalog Number :

Device Description : Spark 10 / Apt - Refinement

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Spark - 00889989084818 Catalog Number :

Device Description : Spark 10 / Apt - Reorder

Device Class : 2

Duns Number: 154614119

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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