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) (3) AGENT, TOOTH BONDING, RESIN (KLE) (3) CEMENT, DENTAL (EMA) (3) MATERIAL, TOOTH SHADE, RESIN (EBF) (1)

Premarket Exempt

Yes No

Clear

Resilience - 00190730000125 Catalog Number :

Device Description : Gel Etchant Small Syringe 4gm (.14oz) w/5 tips

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000132 Catalog Number :

Device Description : Gel Etchant Medium Bottle 57gm (2oz) per bottle

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000149 Catalog Number :

Device Description : Liquid Etchant Large Bottle 29.6mL (1 fl oz) per bottle

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000156 Catalog Number :

Device Description : Powder/Liq Ionomer Starter Kit 50gm powder and 50mL liquid

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000163 Catalog Number :

Device Description : Powder/Liq Ionomer Econo Kit 100gm powder and 100mL liquid

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000170 Catalog Number :

Device Description : Paste/Paste Ionomer Econo Kit 4x 5gm base/4x 5gm catalyst

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000187 Catalog Number :

Device Description : Light-Activated Syringe Kit 4x 3.5gm syringes

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000194 Catalog Number :

Device Description : Light-Activated Intro Kit 3.5gm syringe and 3mL sealant

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000200 Catalog Number :

Device Description : LV Flowable Composite Kit

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000217 Catalog Number :

Device Description : Primer-Activated Syringe Kit 4x 3.5gm syringes

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

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