ORTHO TECHNOLOGY, INC.

Address:1 Southern Ct.,West Columbia,SC,29169,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) (6) CEMENT, DENTAL (EMA) (2) BRACKET, PLASTIC, ORTHODONTIC (DYW) (1) MATERIAL, TOOTH SHADE, RESIN (EBF) (1)

Premarket Exempt

Yes No

Clear

Resilience - 00190730000224 Catalog Number :

Device Description : Primer-Activated Intro Kit 3.5gm syringe and 3mL primer

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000231 Catalog Number :

Device Description : Light-Activated Syringe 3.5gm per syringe

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000248 Catalog Number :

Device Description : Light-Activated Capsules 40x .35gm capsules

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000255 Catalog Number :

Device Description : Light-Activated Sealant Resin 7mL per bottle

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000262 Catalog Number :

Device Description : Primer-Activated Syringe 3.5gm per syringe

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000279 Catalog Number :

Device Description : Primer-Activated Catalyst 9mL per bottle

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000286 Catalog Number :

Device Description : Light-Cure Band Cement Kit 6x 5gm syringes

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000293 Catalog Number :

Device Description : Light-Cure Band Cement Syringe 5gm per syringe

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000309 Catalog Number :

Device Description : Light-Activated Capsule Kit 40x .35gm capsules

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Avalon - 00190730000316 Catalog Number :

Device Description : Avalon Composite 018 UR1 Roth Rx +12º Tor. +5º Ang.(10PK)

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

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