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

MATERIAL, IMPRESSION (ELW) (3) RESIN, DENTURE, RELINING, REPAIRING, REBASING (EBI) (3) Bracket, ceramic, orthodontic (NJM) (2) Headgear, extraoral, orthodontic (DZB) (2)

Premarket Exempt

Yes No

Clear

Masel - 00190707000363 Catalog Number :

Device Description : SAFETY RELEASE MODULE HEAVY FORCE

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Masel - 00190707000370 Catalog Number :

Device Description : FLAVOR DROPS-STRAWBERRY

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Masel - 00190707000387 Catalog Number :

Device Description : FLAVOR DROPS-MINT

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Masel - 00190707000394 Catalog Number :

Device Description : FLAVOR DROPS-WATERMELON

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Ultracryl - 00190707000400 Catalog Number :

Device Description : ULTRACRYL II POWDER

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Ultracryl - 00190707000417 Catalog Number :

Device Description : ULTRACRYL II POWDER

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Ultracryl - 00190707000424 Catalog Number :

Device Description : ULTRACRYL II LIQUID

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

NeoLucent Plus - 00190707000431 Catalog Number :

Device Description : NeoLucent® Plus™ .022 Kit U/L 3X3 Roth HK

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Genesis-C - 00190707000448 Catalog Number :

Device Description : Genesis-C 022 Roth Kit 5x5

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Masel - 00190707000455 Catalog Number :

Device Description : COMFORT NECK PADS BLACK/BRIGHT BLUE

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

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