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

Scaler, Periodontic (EMN) (8) Plier, Orthodontic (JEX) (2)

Premarket Exempt

No Yes

Clear

DENALI - 00810042120327 Catalog Number :

Device Description : Ligature Director, Single Ended

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120334 Catalog Number :

Device Description : No. 7 Wax Spatula

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120341 Catalog Number :

Device Description : No. 24 Cement Spatula, Flexible Blade

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120358 Catalog Number :

Device Description : No. 24A Cement Spatula, Rigid Blade

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120365 Catalog Number :

Device Description : Hammerhead NITI Cinch Back Plier

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120372 Catalog Number :

Device Description : Hook Crimping Plier

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120389 Catalog Number :

Device Description : NITI Ice Instrument

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120396 Catalog Number :

Device Description : Poistive Positioner

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120402 Catalog Number :

Device Description : The Twister Cinch Back Instrument - .022

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120419 Catalog Number :

Device Description : The Twister Cinch Back Instrument - .030

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

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