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) (9) BRACKET, METAL, ORTHODONTIC (EJF) (1)

Premarket Exempt

No Yes

Clear

Damon Clear - 00889989000542 Catalog Number :

Device Description : U3L .022 +11/+5/0 SUPER TQ HK

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear - 00889989000559 Catalog Number :

Device Description : U4&5R .022 -11/+2/0 HK STD TQ

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear - 00889989000566 Catalog Number :

Device Description : U4&5L .022 -11/+2/0 HK STD TQ

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear 2 - 00889989000573 Catalog Number :

Device Description : U1R .022 +15/+5/0 STD TQ

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear 2 - 00889989000580 Catalog Number :

Device Description : U1L .022 +15/+5/0 STD TQ

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear 2 - 00889989000597 Catalog Number :

Device Description : U2R .022 +6/+9/0 STD TQ

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear 2 - 00889989000603 Catalog Number :

Device Description : U2L .022 +6/+9/0 STD TQ

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear 2 - 00889989000610 Catalog Number :

Device Description : U3R .022 +7/+5/0 STD TQ HK

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Damon Clear 2 - 00889989000627 Catalog Number :

Device Description : U3L .022 +7/+5/0 STD TQ HK

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 10

Inspire ICE - 00889989001396 Catalog Number :

Device Description : Clear Braces - Quad - L1&2R 18 ROTH -1/0/0

Device Class :

Duns Number: 154614119

Premarket Exempt : No

Product Code : EJF

Prescription Use : Yes

Device Count : 5

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