ORTHO TECHNOLOGY, INC.

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

AGENT, TOOTH BONDING, RESIN (KLE) (4) BRACKET, METAL, ORTHODONTIC (EJF) (2) BAND, ELASTIC, ORTHODONTIC (ECI) (1) Bracket, ceramic, orthodontic (NJM) (1) Headgear, extraoral, orthodontic (DZB) (1) MATERIAL, TOOTH SHADE, RESIN (EBF) (1)

Premarket Exempt

No Yes

Clear

Votion - 00190730000002 Catalog Number :

Device Description : Votion .018 R UR1 +12T 5A 0O (10PK)

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : Yes

Device Count : 1

PURE - 00190730000019 Catalog Number :

Device Description : PURE® Roth 018 UR1 Rx +11º Tor. +5º Ang.(10PK)

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Creatures of the Sea - 00190730000033 Catalog Number :

Device Description : Elastics Amber Medium 1/8 Manta Ray 50 pks of 100

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000057 Catalog Number :

Device Description : LV Flowable Composite Syringe 2gms. + 10 syringe tips

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Pinnacle - 00190730000064 Catalog Number :

Device Description : Pinnacle .018 R UR1 +12T 5A 0O (10PK)

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Multi-Adjustable Facemask - 00190730000071 Catalog Number :

Device Description : Multi-Adjustable Facemask Blue

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000088 Catalog Number :

Device Description : Gel Etchant Syringe Kit 4x 4gm w/20 tips

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000095 Catalog Number :

Device Description : Liquid Etchant Small Bottle 7mL (.23 fl oz) per bottle

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000101 Catalog Number :

Device Description : Gel Etchant Large Bottle 226gm (8oz) per bottle

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Resilience - 00190730000118 Catalog Number :

Device Description : Gel Etchant Large Syringe 12gm (.423oz) w/20 tips

Device Class : 2

Duns Number: 781772017

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

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