ORTHO ORGANIZERS, INC.

Address:1822 ASTON AVE,CARLSBAD,CA,92008,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

Headgear, extraoral, orthodontic (DZB) (9) Bracket, ceramic, orthodontic (NJM) (1)

Premarket Exempt

No Yes

Clear

Safety Force - 00190707000462 Catalog Number :

Device Description : SAFETY FORCE MODULES MEDIUM BLUE

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Safety Force - 00190707000479 Catalog Number :

Device Description : SAFETY FORCE MODULES MEDIUM BLACK

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Safety Force - 00190707000486 Catalog Number :

Device Description : SAFETY FORCE MODULES HEAVY BLUE

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Safety Force - 00190707000493 Catalog Number :

Device Description : SAFETY FORCE MODULES HEAVY BLACK

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Masel - 00190707000509 Catalog Number :

Device Description : MULTI-ADJUSTABLE FACEMASK BLUE

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Masel - 00190707000516 Catalog Number :

Device Description : MULTI-ADJUSTABLE FACEMASK RED

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Masel - 00190707000523 Catalog Number :

Device Description : MULTI-ADJUSTABLE FACEMASK USA

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Masel - 00190707000530 Catalog Number :

Device Description : MULTI-ADJUSTABLE FACEMASK PEARL

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

NeoLucent Plus - 00190707000547 Catalog Number :

Device Description : NeoLucent® Plus™ .018 Kit U 5x5 Roth HKS

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Masel - 00190707000554 Catalog Number :

Device Description : FACEBOW 045 ONE FOR ALL

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

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