ORTHO ORGANIZERS, INC.

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

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN (DYH) (7) BRACKET, METAL, ORTHODONTIC (EJF) (1) Bracket, ceramic, orthodontic (NJM) (1) MATERIAL, TOOTH SHADE, RESIN (EBF) (1)

Premarket Exempt

No Yes

Clear

Everest - 00190707000004 Catalog Number :

Device Description : Light-Cure Adhesive Syringe

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

NeoLucent Plus - 00190707000011 Catalog Number :

Device Description : NeoLucent Plus .022 Kit U/L 5X Roth HKS

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Aria - 00190707000028 Catalog Number :

Device Description : Aria™ .022 LR3 0T 3A 0O

Device Class : 1

Duns Number: 062165188

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Everest - 00190707000097 Catalog Number :

Device Description : Light-Cure Orthodontic Adhesive Syringe Kit

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Everest - 00190707000103 Catalog Number :

Device Description : No-Mix Orthodontic Adhesive(Primer-Activated) Syringe Kit

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Everest - 00190707000110 Catalog Number :

Device Description : Light-Cure Adhesive Syringe

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Everest - 00190707000127 Catalog Number :

Device Description : Light-Cure Adhesive Capsules

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Everest - 00190707000134 Catalog Number :

Device Description : Light-Cure Orthodontic Adhesive Sealant Resin

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Everest - 00190707000141 Catalog Number :

Device Description : No-Mix Adhesive Syringe

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Everest - 00190707000158 Catalog Number :

Device Description : No-Mix Primer

Device Class : 2

Duns Number: 062165188

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

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