ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

Address:7851 Airpark Rd Ste 202,GAITHERSBURG,MD,20879,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

Plier, Orthodontic (JEX) (4) Bracket, Metal, Orthodontic (EJF) (2) Spring, Orthodontic (ECO) (2) Retainer, Screw Expansion, Orthodontic (DYJ) (1) Wire, Orthodontic (DZC) (1)

Premarket Exempt

No Yes

Clear

OSE - 00810042120013 Catalog Number :

Device Description : Palatal Swivel Key

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : No

Device Count : 1

OSE - 00810042120020 Catalog Number :

Device Description : .010 Short Twisted Preformed Stainless Steel Ligature Ties

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : No

Device Count : 1

OSE - 00810042120037 Catalog Number :

Device Description : Neet™ Nickel Titanium Molar Separating Springs

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : No

Device Count : 1

OSE - 00810042120044 Catalog Number :

Device Description : Neet™ Nickel Titanium Bi-Molar Separating Springs

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : No

Device Count : 1

OSE - 00810042120051 Catalog Number :

Device Description : Bonding Pads - Bicuspid Narrow

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : No

Device Count : 1

OSE - 00810042120068 Catalog Number :

Device Description : Bonding Pads - Lateral

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : No

Device Count : 1

DENALI - 00810042120075 Catalog Number :

Device Description : Mathieu Needle Holder - Slim

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120082 Catalog Number :

Device Description : Mathieu Needle Holder - Standard

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120099 Catalog Number :

Device Description : Mathieu Needle Holder - Slim Curved

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120105 Catalog Number :

Device Description : Mathieu Needle Holder - Wide

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

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